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CliniMACS® Cell Separation System, Product catalog 2008

1. D 4 N as vA e FN i on D NN OU bg Un UJ et U www miltenyibiotec com 42 un pe O dud Q Ke dud C Distributors products for clinical use Argentina Australia Austria Bahrain Belarus Brazil Bulgaria Canada Chile China Colombia Croatia Cyprus Czech Republic Ecuador Egypt 43 Lab Systems S A Miltenyi Biotec Australia Pty Ltd Miltenyi Biotec GmbH Al Yamama Medbioscience Miltenyi Biotec B V Ambriex S A Epsilon amp Epsilon Medical S A Miltenyi Biotec Inc UB Ursula Biggemann y Cia Ltda Miltenyi Biotec Trading Shanghai Co Ltd Shanghai Office Miltenyi Biotec Trading Shanghai Co Ltd Beijing Office Equimed Ltda MEDIVA d o o Epsilon amp Epsilon Medical S A BIOHEM spol s r o Frisonex Al Yamama Quesada 5916 CP 1431 Buenos Aires Ciudad Aut noma de Buenos Aires Argentina Unit 16 A 2 Eden Park Drive North Ryde NSW 2113 Australia Friedrich Ebert Stra e 68 51429 Bergisch Gladbach Germany Al Saif Medical Centre Ibn Khaldoun Street Amman Jordan Nezavisimosti av 107 11 220114 Minsk Belarus Postbus 85183 3508 AD Utrecht The Netherlands Rua Tupi 535 Santa Cecilia 01233 907 Sao Paulo Brazil Apollon Tower 15 A3 64 L Riankour str 11523 Athens Greece 12740 Earhart Avenue Auburn CA 95602 USA Vitacura 2909 Of 1007 Santiago Las Cond
2. Cell Separation System Product catalog 2008 Product overview Page Product Regulatory status Availability Order no CliniMACS Plus Instrument 7 CliniMACS Plus Instrument CE Europe CAN AUS US 151 01 7 CliniMACS Plus Upgrade Kit Software Europe CAN AUS US 755 16 CliniMACS Service Contracts 8 CliniMACS Full Service Agreement Europe 160 000 973 8 CliniMACS Maintenance Europe 160 000 974 8 CliniMACS Premium Service Agreement CAN US 160 000 701 8 CliniMACS Basic Service Agreement CAN US 160 000 702 CliniMACS Tubing Sets 9 CliniMACS Tubing Set CE Europe CAN AUS US 161 01 9 CliniMACS Tubing Set LS CE Europe CAN AUS US 162 01 10 CliniMACS Tubing Set for Research Use For research use only not for use in humans US 165 01 10 CliniMACS Tubing Set LS for Research Use For research use only not for use in humans US 168 01 11 CliniMACS Depletion Tubing Set CE Europe US 261 01 11 CliniMACS Depletion Tubing Set For research use only not for use in humans US CAN AUS 266 01 for Research Use 12 CliniMACS Tubing Set 600 for Research Use For research use only not for use in humans Worldwide 166 01 12 CliniMACS Tubing Set 150 for Research Use For research use only not for use in humans Worldwide 167 01 For availability in your country please contact your local representative 1 The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13
3. CliniMACS MicroBeads are for research use only and not for use in humans Unless otherwise specifically indicated Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use 29 Single step NK and NKT cell enrichment procedure A Before enrichment B After enrichment CD56 PE CD56 PE CIAM CD3 FITC CD3 FITC Figure 1 Flow cytometric analysis of CD56 enriched cells using the CliniMACS CD56 System Two step NK cell enrichment procedure C After CD3 depletion and CD56 enrichment A Before enrichment B After CD3 depletion 24 CD56 PE CD56 PE CD56 PE Ei A A CD3 FITC CD3 FITC CD3 FITC Figure 2 Flow cytometric analysis of CD3 depleted cells B followed by the analysis of CD56 enriched cells C using the CliniMACS CD3 CD56 System ww w miltenyibiotec com B cells CliniMACS CD19 Cell Depletion Product CliniMACS CD19 Reagent Regulatory status Capacity max Availability CE 5 x10 CD19 cells from 40 x 10 total cells Europe US 179 01 Order no CliniMACS CD19 MicroBeads 5 x10 CD19 cells from 40 x 10 total cells For research use only US CAN AUS 193 01 not for use in humans For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND applicat
4. Schnurr M et al 2005 Blood 105 6 2465 2472 Davis LD et al 2005 Proc Amer Assoc Cancer Res 46 Abstr no 3466 Ln gt d Related CliniMACS Products CliniMACS Anti Biotin MicroBeads 192 01 CliniMACS Anti Biotin Reagent 173 01 CliniMACS CD19 MicroBeads 193 01 CliniMACS CD19 Reagent 179 01 m Related MACS Products Blood Dendritic Cell Enumeration Kit human 130 091 324 CD1c BDCA 1 PE human 130 090 508 The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans Unless otherwise specifically indicated Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use ww w miltenyibiotec com Dendritic cells CliniMACS CD304 BDCA 4 Cell Enrichment Product Regulatory status Capacity max Availability Order no CliniMACS CD304 BDCA 4 MicroBeads For research use only 0 2 x10 CD304 BDCA 4 cells Worldwide 291 01 not for use in humans from 40 x10 total
5. Capacity max 0 2 x 10 CD1c BDCA 1 cells from 40 x 10 total cells Order no 277 01 Availability Europe US NEW CliniMACS CD1c BDCA 1 CD19 Complete Kit CE marked components from 40 x 10 total cells 0 2 x 10 CD1c BDCA 1 cells Europe NEW 740 03 CliniMACS CD1c BDCA 1 Biotin for Research Use For research use only not for use in humans from 40 x 10 total cells 0 2 x10 CD1c BDCA 1 cells US CAN AUS 255 01 For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Description The CD1c BDCA 1 antigen is expressed on dendritic cells which are CD11c 9 CD123 and represent a major subset of myeloid dendritic cells in human peripheral blood Also the antigen is expressed on a subpopulation of CD19 B cells The CliniMACS CD1c BDCA 1 Biotin Products consist of biotin directly conjugated to CD1c BDCA 1 antibodies One vial contains 5 mL sterile non pyrogenic solution suitable for labeling of up to 0 2x10 CD1c BDCA 1 cells from up to 40x10 total cells Please inquire about recommended device and accessories Applications CliniMACS CD1c BDCA 1 Biotin Products were developed for the enrichment of CD1c BDCA 1 myeloid dendr
6. Feuchtinger et al 2006 Br J Haematol 134 64 76 Un A W N Ld Related MACS Products CD4 FITC human 130 080 501 CD4 APC human 130 091 232 CD8 FITC human 130 080 601 CD8 APC human 130 091 076 Large Scale IFN y Secretion Assay Enrichment Kit human 130 091 329 T cell Expansion Bag 6 ports 130 091 459 T cell Expansion Bag tube 130 091 458 T cell Activation Expansion Kit human Anti IFN y PE human 130 091 441 130 091 653 The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans Unless otherwise specifically indicated Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use ww w miltenyibiotec com Antigen specific T cells Restimulation of antigen specific T cells is easily performed in vitro Depending on the nature of the specific antigen cells are O activated T cell incubated for 3 16 hours As a result the responding cells rapidly Q
7. Miltenyi Biotec B V www miltenyibiotec com Department of Laboratory Supplies amp Equipment Kungla Street 2 76505 Saue Estonia 10 rue Mercoeur 75011 Paris France Friedrich Ebert Strate 68 51429 Bergisch Gladbach Germany Apollon Tower 15 A3 64 L Riankour str 11523 Athens Greece Rm 2301 No 319 Xianxia Rd Fareast International Plaza A Shanghai 200051 P R China Dereglye u 2 1036 Budapest Hungary GH 8 505 Paschim Vihar New Delhi 87 India Graha Atrium Lt 6 Suite 6 02A Jalan Senen Raya No 135 Jakarta Pusat 10410 Indonesia North industrial area 4 60850 Shoham Israel via Persicetana 2 D 40012 Calderara di Reno Bologna Italy Nittsu Eitai Building 5F 16 10 Fuyuki Koto ku 135 0041 Tokyo Japan Al Saif Medical Centre Ibn Khaldoun Street Amman Jordan Al Awadi Towers Tower No 3 6th Floor Ahmend Al Jaber Street 72263 Da A Al Salem Kuwait Dzelzavas iela 120M Riga 1021 Latvia Al Saif Medical Centre Ibn Khaldoun Street Amman Jordan Laisves pr 75 Vilnius 2022 Lithuania Postbus 85183 3508 AD Utrecht The Netherlands Phone 372 65 15 159 Fax 37265 15111 Phone 33 1 56 98 16 16 Fax 33 1 56 98 16 17 Phone 49 2204 8306 0 Fax 49 2204 85197 Phone 30 210 6996 191 Fax 30 210 6920 210 Phone 86 21 6235 1005 Fax 86 21 6235 0953 Phone 361 388 3114 Fax 361 368 5721 Phone 91 11 6543 8094 Fax 91 11 2528 7644 Phone 62 21 3509 544 Fax 62 2
8. PO Box 92690 11663 Riyadh Saudi Arabia 100 Beach Road 428 06 to 28 08 Shaw Tower Singapore 189702 Zl tovska 2211 911 01 Tren n Slovakia PO BOX 13004 0014 Clubview Centurion South Africa Phone 60 3 6201 9060 Fax 60 3 6201 9062 Phone 52 55 5281 4718 Fax 52 55 5281 4722 Phone NL 0800 4020 120 Fax NL 0800 4020 100 Phone 61 02 8877 7400 Fax 61 02 9889 5044 Phone 44 2890 448800 Fax 44 2890 449400 Phone 962 6 4655 166 Fax 962 6 4655 167 Phone 92 21 4555 351 Fax 92 21 4532 574 Phone 51 1 440 9678 Fax 51 1 422 3701 Phone 48 12 665 3131 Fax 48 12 665 3132 Phone 351 218 421 430 Fax 351 218 421 439 Phone 962 6 4655 166 Fax 962 6 4655 167 Phone 40 21 230 74 30 Fax 40 21 230 71 30 Phone 7 495 414 68 15 Fax 7 495 414 68 20 Phone 966 1 4125 252 Fax 966 1 4124 141 Phone 65 6238 8183 Fax 65 6238 0302 Phone 421 32 6524 998 Fax 421 32 6525 792 Phone 27 82 484 7934 Fax 27 12654 4614 In the United States CliniMACS products for clinical use are available only under an approved Investigational Device Exemption IDE www transmedic com sg uniparts uniparts com mx www uniparts com mx macs miltenyibiotec nl www miltenyibiotec com macs miltenyibiotec com au www miltenyibiotec com vector ua ltd co uk modhafar alyamamagroup com www alyamamagroup com tascientific yahoo com Ifquirozaterra com pe www inmunochem com medianus medianus net w
9. 179 01 193 01 272 01 281 01 191 01 277 01 740 03 255 01 291 01 173 01 192 01 701 06 257 01 700 25 705 25 1 The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans 2 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE www miltenyibiotec com Product overview Page 38 38 38 38 39 39 39 39 39 39 39 39 39 39 39 39 40 40 40 41 41 41 42 42 42 42 Product Accessories Cell Expansion Bag tube Cell Expansion Bag 6 ports Cell Expansion Bag tube Cell Expansion Bag 6 ports Cell Differentiation Bag tube 100 Cell Differentiation Bag tube 250 Cell Differentiation Bag tube 500 Cell Differentiation Bag 6 ports 100 Cell Differentiation Bag 6 ports 250 Cell Differentiation Bag 6 ports 500 Cell Differentiation Bag tube 100 Cell Differenti
10. 102 814 819 9 Elmaagacli etal 2004 Onkologie 27 Suppl 3 0194 10 Ruggeri et al 2002 Science 295 2097 2100 11 Farag et al 2002 Blood 100 6 1935 1947 SD uU A W MJ 28 D 4 N as vA e FT i on D N OU ied Un UJ lt x U D 4 N Z Y a e i Q D Y OU L Un UJ lt x U NK cells Kit components not available in the US CliniMACS CD3 CD56 Reagent Combination 704 01 1 vial CliniMACS CD3 Reagent e 1 vial CliniMACS CD56 Reagent CliniMACS CD3 CD56 Complete Kit 740 04 1 vial CliniMACS CD3 Reagent e 1 vial CliniMACS CD56 Reagent 1 CliniMACS Tubing Set e 1 CliniMACS Depletion Tubing Set e 2 units CliniMACS PBS EDTA Buffer 3x1L Ld Related CliniMACS Products CliniMACS CD3 MicroBeads 176 01 CliniMACS CD3 Reagent 273 01 CliniMACS CD3 CD19 Reagent Combination 704 00 1 Notavailable in the US B Related MACS Products CD3 FITC human 130 080 401 The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE
11. 130 074 153 130 074 251 130 074 252 130 074 253 181 01 187 01 189 01 185 01 186 01 188 01 183 01 190 01 180 01 184 01 In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans 2 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE 3 The Cell Expansion Bags and the Cell Differentiation Bags are manufactured and controlled under an ISO 13485 certified quality system These products are available in Europe as CE marked medical devices www miltenyibiotec com E D 1 N Z NN e ES C es D Ge oO Un UI lt E E U D 41 Un eS N a e rum C D N OU L Un UW lt x U CliniMACS Plus Instrument CliniMACS Technology The CliniMACS Plus Instrument is an automated cell separation system based on MACS Technology It enables the operator to perform clinical scale magnetic enrichment of target cells or depletion of unwanted cells in a closed and sterile system The cells are first magnetically l
12. 2001 J Hematother Stem Cell Res 10 427 429 7 Dietz etal 2000 J Hematother Stem Cell Res 9 1 95 101 8 Curti et al 2004 Leukemia amp Lymphoma 45 7 1419 1428 BR Ww Fi Kit components not available in the US CliniMACS CD14 Complete Kit 281 01 1 vial CliniMACS CD14 Reagent e 1 CliniMACS Tubing Set e 3x 1 Lof CliniMACS PBS EDTA Buffer M Related MACS Products CD14 FITC human 130 080 701 CD15 FITC human 130 081 101 The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an IS0 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans Unless otherwise specifically indicated Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use 32 D 4 N z vA e i on D N OU ied Un UJ lt x U D 4 N Z Y a e i Q D N OU Un UW lt x U Dendritic cells CliniMACS CD1c BDCA 1 Cell Enrichment Product CliniMACS CD1c BDCA 1 Biotin CE Regulatory status
13. are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Non ZS ki A gt CliniMACS MicroBeads are for research use only and not for use in humans D 4 N Z Y a e i Q D N OU Un UW lt x U Unless otherwise specifically indicated Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use 23 ww w miltenyibiotec com Antigen specific T cells CliniMACS Antigen specific T cell enrichment Cytokine secretion is a hallmark of functionality of antigen specific T cells Large amounts of cytokines are produced by effector and memory T cells after short term restimulation with their specific antigen For a multitude of challenges it is of great interest to use antigen specific T cells Such applications could include prevention or managing of infection with Cytomegalovirus CMV Adenovirus or Epstein Barr Virus EBV After immunosuppression i e in the course of chemotherapy or organ transplantation such infections pose life threatening complications which sometimes are hard to fight by conventional means The treatment of tumors which are resistant to conventional therapy may become another field of application for antigen specifi
14. 250 mL and 500 mL Cell Expansion Bags are compartimental ized with easy to open seals for expandable culture volumes as cell numbers increase during culture period There is no need for changing culture vessel The three compartments allow for expandable volumes from 8mL up to 100 mL Cell Expansion Bag tube with incremental culture volumes As culture volume increases seals can easily be opened to give larger culture volumes No transfer to other bags is necessary 37 www miltenyibiotec com Accessories Cell Expansion Bags Product Content Cell Expansion Bag tube 5 Bags Regulatory status CE Capacity upto 100mL Availability Europe Order no 200 074 301 Cell Expansion Bag 6 ports 5 Bags CE up to 100 mL Europe 200 074 302 Cell Expansion Bag tube 5 Bags For research use only up to 100 mL US CAN AUS 130 074 351 Cell Expansion Bag 6 ports 5 Bags For research use only 7 up to 100 mL US CAN AUS 130 074 352 For availability in your country please contact your local representative 1 The Cell Expansion Bags are manufactured by Miltenyi Biotec GmbH and controlled under an ISO 13485 certified quality system These products are available in Europe as CE marked medical devices 2 Manufactured by Miltenyi Biotec GmbH under an ISO 9001 certified quality system Description Cell Expansion Bags are gas permeable and transparent for microscopy They hav
15. Bone Marrow Transplant 29 Suppl 2 199 References 1 13 16 16 Martin Henao et al 2002 ISCT Barcelona 100 CliniMACS CD34 Cell Enrichment Product Regulatory status Capacity max Availability Order no CliniMACS CD34 Reagent CE 0 6x10 CD34 cells Europe CAN AUS US 171 01 from 60 x10 total cells CliniMACS CD34 Complete Kit CE marked 0 6 x10 CD34 cells Europe 178 01 components from 60 x10 total cells CliniMACS CD34 Complete Kit CE marked 0 6 x10 CD34 cells Europe 177 01 with Accessories components from 60 x10 total cells CliniMACS CD34 Complete LS Kit CE marked 1 2 x10 CD34 cells Europe 170 01 components from 120 x10 total cells CliniMACS CD34 Complete LS Kit CE marked 1 2 x10 CD34 cells Europe 169 01 with Accessories components from 120 x10 total cells CliniMACS CD34 MicroBeads For research use only 0 6 x10 CD34 cells US 175 01 not for use in humans from 60 x 10 total cells For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Description cells but is also present on endothelial The CliniMACS CD34 Products The CD34 antigen is a single transmembrane progenitor cells The CD34 antigen is consist of superparamagnetic glycoprotein that is mainly ex
16. CD133 2 293C3 PE 196 01 2 vials CliniMACS CD133 Reagent human 130 090 853 1 vial CliniMACS CD133 Reagent 1 CliniMACS Tubing Set LS CD133 2 293C3 APC D D human 130 090 854 e 1 CliniMACS Tubing Set e 3x1L CliniMACS PBS EDTA Buffer E CD34 FITC human 130 081 001 e 3x1L CliniMACS PBS EDTA Buffer ae CD34 PE human 130 081 002 CliniMACS CD133 Complete LS Kit with SCH SE CD34 APC human 130 090 954 CliniMACS CD133 Complete Kit with Accessories 199 01 SC CD45 FITC human 130 080 202 Accessories 198 01 e 2 vials CliniMACS CD133 Reagent es a CD45 PE human 130 080 201 e 1 vial CliniMACS CD133 Reagent e 1 CliniMACS Tubing Set LS CD45 APC human 130 091 230 e 1 CliniMACS Tubing Set e 3x1 L CliniMACS PBS EDTA Buffer e 3x1 L CliniMACS PBS EDTA Buffer e 1 Pre System Filter e 1 Pre System Filter e 1 Luer Spike Interconnector ln l The CliniMACS System components Reagents Tubing Sets Instruments e 1 Luer Spike Interconnector 1 Transfer Bag 150 mL and PBS EDTA Buffer are manufactured and controlled under an e 1 Transfer Bag 150 mL ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for u
17. CD19 PE human 130 091 247 hematologic cell populations in combination with the CliniMACS System This approach maintains the stem cells and The CliniMACS System components Reagents Tubing Sets Instruments immune effector cells such as NK cells in and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for References use only under an approved Investigational New Drug IND application or 1 Gordon et al 2002 Bone Marrow Transplant 30 69 74 Investigational Device Exemption IDE 2 Chen etal 2006 Brit J Haem 135 524 532 the cellular product CliniMACS MicroBeads are for research use only and not for use in humans Unless otherwise specifically indicated Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use D 4 N z vA e i on D N OU ied Un UJ lt x U www miltenyibiotec com 20 T cells CliniMACS CD4 Cell Separation Product Regulatory status Capacity max Availability Order no CliniMACS CD4 Reagent CE 12x10 CD4 cells Europe US 276 01 from 40 x 10 total cells CliniMACS CD4 MicroBeads For research use only 12x10 CD4 cells US CAN AUS 304 01 notforuseinhumans from 40x10 total
18. CD34 CFU Colony forming units BFU Blast forming units O Lymphoid Stem Cell CD133 CD34 O Pro B Cell CD133 CD34 QO O CFU Bas Pre B Cell CD347 CD34 Figure 1 The early hematopoetic progenitor cell marker CD133 is ancestral to CD34 n 11 Purity CD133 96 94 Recovery CD133 90 69 CD3 log depletion 4 2 Table 1 CliniMACS CD133 enrichment results from PBSCs of allogeneic donors nd not determined References 19 21 15 n 84 n 12 93 97 81 69 3 8 nd www miltenyibiotec com Stem and progenitor cells CliniMACS CD133 AC133 Cell Enrichment Product Regulatory status Capacity max Availability Order no CliniMACS CD133 Reagent CE 0 6 x10 CD133 cells Europe US 172 01 from 60 x10 total cells CliniMACS CD133 Complete Kit CE marked components 0 6 x10 CD133 cells Europe 196 01 from 60 x10 total cells CliniMACS CD133 Complete Kit CE marked components 0 6 x10 CD133 cells Europe 198 01 with Accessories from 60 x10 total cells CliniMACS CD133 Complete LS Kit CE marked components 1 2 x10 CD133 cells Europe 197 01 from 120 x 10 total cells CliniMACS CD133 Complete LS Kit CE marked components 1 2x10 CD133 cells Europe 199 01 with Accessories from 120 x 10 total cells CliniMACS CD133 MicroBeads For research use only 0 6 x10 CD133 cells US CAN AUS 195 01 not for use in humans from 60 x10 total cells For availability in your country please contact your lo
19. Investigational Device Exemption IDE approaches such as in the HIV setting CD8 PE human 130 091 084 g U CliniMACS MicroBeads are for research use only and not for use in CD8 APC human 130 091 076 ct nmang CD14 FITC human 130 080 701 2 Unless otherwise specifically indicated Miltenyi Biotec products and CD14 APC human 130 091 243 c services are for research only and not for therapeutic or diagnostic use Anti Biotin FITC 130 090 857 21 www miltenyibiotec com T cells CliniMACS CD8 Cell Depletion Product CliniMACS CD8 Reagent Regulatory status Capacity max Availability CE 4x10 CD8 cells from 40 x10 total cells Europe US 275 01 Order no CliniMACS CD8 MicroBeads 4x10 CD8 cells from 40 x10 total cells For research use only US CAN AUS 308 01 not for use in humans For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Description The CD8 antigen a co receptor for MHC class molecules is expressed strongly on cytotoxic T cells and dimly on a subset of NK cells The CliniMACS CD8 Products consist of superparamagnetic iron dextran particles directly conjugated to CD8 antibodies One vial contains 7 5 mL sterile non pyrogenic solution suitable fo
20. a buffy coat using the CliniMACS CD3 CD19 System Ld Related CliniMACS Products CliniMACS CD3 CD56 Reagent Combination 704 01 CliniMACS CD3 Reagent 273 01 CliniMACS CD19 Reagent 179 01 CliniMACS CD56 Reagent 271 01 1 Notavailable in the US Related MACS Products CD14 PE human 130 091 242 CD15 PE human 130 091 375 CD20 FITC human 130 091 108 CD45 FITC human 130 080 202 References 1 Barfield et al 2004 Cytotherapy 6 1 6 2 Gordon et al 2002 Bone Marrow Transplant 30 69 74 The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans Unless otherwise specifically indicated Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use 18 D 4 N z vA e i on D N OU ied Un UJ lt x U T cells CliniMACS T Cell Separation T cells play critical roles in the regulation of immune responses and are responsible for mediat
21. begin to secrete cytokines CliniMACS IFN gamma Catchmatrix Reagent Upon labeling with the CliniMACS IFN gamma Catchmatrix Reagent cytokine specific antibodies are attached onto the surface of all leukocytes via binding to the CD45 antigen gt s secreted Cells are allowed to secrete cytokines for a cytokine period of 45 minutes at 37 C The secreted cytokines IFN y are captured by the CliniMACS IFN gamma Catchmatrix Reagent exclusively on the surface of the cytokine secreting cells cytokine secreting cell CliniMACS IFN gamma The cells are then labeled with the 4 Enrichment CliniMACS IFN gamma Enrichment Reagent Reagent The cells are now ready for magnetic enrichment aw a Magnetic enrichment of the cytokine secreting cells is achieved using the CliniMACS System and specifically designed software IFN y a et Detection Optional For flow cytometric analysis the Antibody cytokine secreting cells can be stained with fluorochrome conjugated Cytokine a s Detection Antibodies pz Figure 1 Principle of the CliniMACS Cytokine Capture System IFN gamma D 4 N z vA e i on D N OU bg Un UJ lt x U www miltenyibiotec com 26 D 4 N eS N a e i C D N D LO Un d lt U NK cells CliniMACS Natural killer cell enrichment Natural killer NK cells are known to be first in the line of defense agai
22. cells For availability in your country please contact your local representative Description A Before enrichment B After enrichment In peripheral blood CD304 BDCA 4 mS 92 7 Neuropilin 1 is expressed on human plasmacytoid lymphoid dendritic cells which are characterized as being CD303 BDCA 2 CD4 Un CD11c7 CD123P 9 CD45RA CD25 These cells do not express myeloid lineage markers such as CD13 or GD33 CD123 APC CD123 APC CD303 BDCA 2 PE CD303 BDCA 2 PE The CliniMACS CD304 BDCA 4 Figure 1 Flow cytometric analysis of CD304 BDCA 4 enriched cells from leukapheresis harvest using the CliniMACS CD304 MicroBeads consist of superparamagnetic BDCA 4 System iron dextran particles directly conjugated to CD304 BDCA 4 antibodies One vial contains 7 5 mL sterile non Ld Related MACS Products pyrogenic solution suitable for magnetic CD303 BDCA 2 FITC labeling of up to 0 2x10 CD304 BDCA 4 human 130 090 510 cells out of 40x 10 total cells CD303 BDCA 2 PE human 130 090 511 CD123 APC human 130 090 901 Please inquire about recommended device d CD45 FITC human 130 080 202 and accessories CD45 PE human 130 080 201 a Blood Dendritic Cell Applications Enumeration Kit human 130 091 324 CliniMACS CD304 BDCA 4 MicroBeads were developed for enrichment of CD304 BDCA 4 plasmacytoid dendritic The CliniMACS System components Reagents Tubing Sets Ins
23. depletion of large quantities of cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System Itis also designed for a faster depletion of more cells as compared to other CliniMACS Tubing Sets References 1 Fritsch etal 2004 Bone Marrow Transplant 33 Suppl 1 595 2 Fritsch et al 2004 Cytotherapy 6 4 432 E Related CliniMACS Products CliniMACS Plus Upgrade Kit Software 755 16 The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans www miltenyibiotec com Figure 1 CliniMACS Depletion Tubing Set CliniMACS Tubing Sets CliniMACS Tubing Sets 150 and 600 for Research Use Product Components Regulatory status Capacity max Availability Order no CliniMACS Tubing Set 600 5 Tubing Sets For research use only 20 x 10 total cells Worldwide 166 01 for Research Use not for use in humans CliniMACS Tubing Set 150 5 Tubing Sets For research use only 10 x10 total cells Worldw
24. in the US Ld Related MACS Products CD20 FITC human 130 091 108 CD3 PE human 130 091 374 CD14 PE human 130 091 242 CD15 PE human 130 091 375 The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans Unless otherwise specifically indicated Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use 30 D 4 N z vA e i on D N OU ied Un UJ lt x U D N Z UD a e ex D N OU J Un UI lt x U Dendritic cells CliniMACS Dendritic cell enrichment Dendritic cells DCs have great potential as cellular vaccines for various diseases Most clinical studies using DCs focus on malignant diseases such as solid tumors or hematologic malignancies However novel indications such as viral infections solid organ transplantation and autoimmune diseases are also being investigated DCs generated from monocytes aft
25. miltenyibiotec com 1 2 Stem and progenitor cells CliniMACS CD34 Enrichment Background Performance haploidentical setting where due to the high The CD34 antigen is expressed on Since its introduction CliniMACS CD34 degree of HLA mismatch GVHD is the major hematopoietic progenitor cells System has been used in numerous clinical cause of transplantation related mortality constituting a small subpopulation trials to provide CD34 progenitor cells with It has also been shown that CliniMACS CD34 of bone marrow cells and peripheral high purity and yield in conjunction with Enrichment is a means to provide tumor blood cells After severe damage excellent passive depletion of unwanted cell depleted stem cell grafts in lymphoma for example after myeloablative cells A review of the performance in the and neuroblastoma patients An emerging conditioning the hematopoietic allogeneic setting is shown in table 1 field for CD34 enriched cells has recently system can be reconstituted by been seen in the depletion of autoreactive transplantation of allogeneic or Clinical results cells from stem cell grafts for diseases such autologous CD34 hematopoietic The concomitant T and B cell depletion as rheumatoid arthritis systemic lupus progenitor cells The concomitant may reduce the incidence of graft versus erythematosus multiple sclerosis and removal of T cells and B cells is host disease GVHD and EBV induced systemic sclerosis important esp
26. of immunomagnetic reagent and tubing set offers high flexibility and versatility for individual separation strategies Different scale applications from rare cell enrichment to bulk depletion are feasible Technical specifications CliniMACS Plus Instrument Model CS2 CE UL Size 70 cm w x 60 cm d 90 130 cm h Weight 35 kg Input voltage 100 240 V AC Power consumption 180 VA The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans CliniMACS Plus Upgrade Kit Software Product CliniMACS Plus Upgrade Kit Software Availability Order no Europe CAN AUS US 755 16 For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Description All CliniMACS Plus Instruments can be up graded to the latest statu
27. status Capacity max Availability Order no CliniMACS Tubing Set 1 Tubing Set CE 60x10 total cells Europe CAN AUS US 161 01 CliniMACS Tubing Set LS 1 Tubing Set CE 120 x 10 total cells Europe CAN AUS US 162 01 For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE 2 Capacity max of labeled cells depends on the software program used Description CliniMACS Tubing Sets consist of pre assembled tubing including a pre column anda selection column The fluid path of the tubing sets is sterile and non pyrogenic One package unit contains one sealed tubing set for single use The CliniMACS Tubing Set 161 01 The CliniMACS Tubing Set was designed for the separation of cells from up to 60 x 10 total cells The CliniMACS Tubing Set LS 162 01 The CliniMACS Tubing Set LS was designed for the separation of cells from up to 120 x10 total cells Please inquire about recommended device and accessories Applications Figure 1 The CliniMACS Tubing Set Figure 2 The CliniMACS Tubing Set LS The CliniMACS Tubing Sets for clinical use were developed for the enrichment or depletion of cells from human heterogeneous hematologic cell populations in combination with the C
28. types in combination with a CliniMACS Tubing Set a CliniMACS Reagent and the CliniMACS PBS EDTA Buffer The portfolio of CliniMACS Reagents includes reagents for the separation Figure 2 The CliniMACS Plus Instrument with installed CliniMACS Tubing Set of stem cells monocytes DCs NK cells B cells and T cell subsets In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE ww w miltenyibiotec com CliniMACS Plus Instrument CliniMACS Plus Instrument The key components of the controls all components of the selection column The peristaltic CliniMACS Plus Instrument are instrument and directs the system to pump controls constant flow rates the integrated micro computer perform reproducible procedures in a throughout the tubing set and the magnetic separation unit the standardized sequence The magnetic ensures together with the pinch peristaltic pump and various pinch separation unit includes a movable valves the controlled flow of buffer valves The integrated computer permanent magnet and a holder for the and cell suspension Key components of the CliniMACS Plus Instrument with installed CliniMACS Tubing Set Buffer Bag Priming Waste Bag Cell Preparation Bag Selection column placed in the magnetic separation unit Pinch valves
29. www miltenyibiotec com NK cells CliniMACS CD56 Cell Enrichment Product Regulatory status CliniMACS CD56 Reagent GE Capacity max Availability Order no 10x10 CD56 cells from 40 x 10 total cells Europe US 271 01 CE marked components CliniMACS CD3 CD56 Reagent Combination 15x10 CD3 cells and 10x10 CD56 cells from 40 x 10 total cells Furope 704 01 CE marked components CliniMACS CD3 CD56 Complete Kit 15 x10 CD3 cells and Europe 10x10 CD56 cells from 40 x10 total cells CliniMACS CD56 MicroBeads For research use only not for use in humans 10x10 CD56 cells from 40 x 10 total cells US CAN AUS For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Description The CD56 antigen is expressed on essentially all human NK cells and its density on the cell membrane is increased after activation The antigen is also present on a unique subset of CD3 T cells NKT cells that mediate non MHC restricted cytotoxicity and on some neural tissues and tumors The CliniMACS CD56 Products consist of superparamagnetic iron dextran particles directly conjugated to CD56 antibodies One vial contains 7 5 mL sterile non pyrogenic solution suit
30. 1 3509 545 Phone 4972 3 977 33 90 Fax 972 3977 3391 Phone 39 051 64 60 411 Fax 439 051 64 60 499 Phone 81 3 5646 8910 Fax 81 3 5646 8911 Phone 962 6 4655 166 Fax 962 6 4655 167 Phone 965 24 3 1344 Fax 965 24 3 5106 Phone 371 6780 2450 Fax 371 6780 2460 Phone 962 6 4655 166 Fax 962 6 4655 167 Phone 370 526 88453 Fax 370 526 88400 Phone Lux 800 24971 Fax Lux 800 24984 In the United States CliniMACS products for clinical use are available only under an approved Investigational Device Exemption IDE kaari saarma oriola com www oriola ee macs miltenyibiotec fr www miltenyibiotec com macs miltenyibiotec de www miltenyibiotec com info eemed gr www eemed gr macs miltenyibiotec com cn www miltenyibiotec com frankdiagn frank diagn hu www frank diagn hu medicons mediconsinc com WwwwW mediconsinc com www transmedic com sg doni transmedic ind com info almog co il www almog co il macs miltenyibiotec it www miltenyibiotec com macs miltenyibiotec jp www miltenyibiotec co jp modhafar alyamamagroup com www alyamamagroup com sales trialphaco com www trialphaco com rigagoriola com www oriola lv modhafar alyamamagroup com www alyamamagroup com giedrius marcinkonis oriola lt www oriola com macs miltenyibiotec nl www miltenyibiotec com 44 un m O dud Q Ke dud KA C un um O dud Q Ke dud a C Distributors products for clinical
31. 485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans 2 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE D 4 N Z N E e 4 ox D N OU WJ Un UJ lt x U 1 www miltenyibiotec com Product overview Page 13 13 13 13 13 13 16 16 16 16 16 16 18 18 18 20 20 21 21 22 22 23 23 25 25 Product Regulatory status Stem and progenitor cells CliniMACS CD34 Reagent EE CliniMACS CD34 Complete Kit CliniMACS CD34 Complete Kit with Accessories CliniMACS CD34 Complete LS Kit CliniMACS CD34 Complete LS Kit with Accessories CliniMACS CD34 MicroBeads CliniMACS CD133 Reagent CE CliniMACS CD133 Complete Kit CliniMACS CD133 Complete Kit with Accessories CliniMACS CD133 Complete LS Kit CliniMACS CD133 Complete LS Kit with Accessories CliniMACS CD133 MicroBeads CliniMACS CD3 CD19 Reagent Combination CliniMACS CD3 CD19 Complete Kit CliniMACS CD3 CD19 Large Scale CE m
32. 5 Biotin Anti Biotin PE Figure 2 Flow cytometric analysis of CD25 depleted cells using the CliniMACS CD25 System Referenced literature In the allogeneic transplantation setting a lg Related MACS Products promising approach to reduce risk of severe depleted from patient s leukapheresis CD25 Biotin human 130 091 235 GVHD may be the selective removal of samples for immunotherapeutic Anti Biotin PE 130 090 756 CD25 alloreactive T cells approaches designed to favor anti tumor Anti Biotin APC 130 090 856 responses CD3 FITC human 130 080 401 Studies in the mouse model paved the CD4 FITC human 130 080 501 way to investigate the role of CD25 CD4 CD8 FITC human 130 080 601 References regulatory T cells for the improvement of Solomon et al 2002 Cytotherapy 4 5 395 406 Andr Schmutz et al 2003 Cytotherapy 7 2 102 108 Amrolia et al 2003 Blood 102 6 2292 2299 Edinger et al 2003 Nat Med 9 1144 1150 Powell et al 2005 J Immunother 28 4 403 11 Baecher Allen et al 2001 J Immunol 167 1245 1253 stem cell transplantation The addition of regulatory T cells either to the graft or DLI may reduce the risk of GVHD f CD25 CD4 regulatory T cells may also be The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components
33. 5x10 CD19 cells from up to 40 x10 total cells respectively Please inquire about recommended device and accessories Applications The CliniMACS CD3 CD19 Products were developed for the simultaneous depletion of unwanted T and B cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System This approach keeps stem and progenitor cells untouched and leaves immune effector cells such as NK cells and dendritic cells in the cellular product Kit components not available in the US CliniMACS CD3 CD19 Reagent Combination 704 00 e 1 vial CliniMACS CD3 Reagent 1 vial CliniMACS CD19 Reagent CliniMACS CD3 CD19 Complete Kit 740 01 e 1 vial CliniMACS CD3 Reagent 1 vial CliniMACS CD19 Reagent e 1 CliniMACS Depletion Tubing Set e 3x1L CliniMACS PBS EDTA Buffer CliniMACS CD3 CD19 Large Scale Complete Kit 740 02 e 2 vials CliniMACS CD3 Reagent e 2 vials CliniMACS CD19 Reagent e 1 CliniMACS Depletion Tubing Set e 3x1L CliniMACS PBS EDTA Buffer www miltenyibiotec com A Before depletion Aa L r e B After depletion LL LL oO oO Ln LA F T cell depletion S Z O o O gt O i E B OB CD3 FITC CD3 FITC C Before depletion D After depletion UCET EE B cell depletion CD14 CD15 PE CD14 CD15 PE CD20 FITC lt 0 01 CD20 FITC Figure 1 Flow cytometric analysis of simultaneous depletion of T and B cells from
34. 857 860 Lang et al 2004 Bone Marrow Transplant 33 25 32 Benesch et al 2004 Br J Haematol 125 1 58 63 COND Li A UN I cl Oo N 0 Flohr etal 2002 Bone Marrow Transplant 29 769 775 LA www miltenyibiotec com Handgretinger et al 2001 Bone Marrow Transplant 27 777 783 Handgretinger et al 2003 Pediatr Transplant 7 Suppl 3 51 55 Handgretinger et ol 2002 Bone Marrow Transplant 29 731 736 A Before enrichment Side Scatter Side Scatter CD34 PE B After enrichment CD34 PE Figure 1 Flow cytometric analysis of CD34 enriched cells from mobilized leukapheresis product using the CliniMACS CD34 System Cells are gated on viable CD45 cells Kit components not available in the US CliniMACS CD34 Complete Kit 178 01 e 1 vial CliniMACS CD34 Reagent 1 CliniMACS Tubing Set e 3x1L CliniMACS PBS EDTA Buffer CliniMACS CD34 Complete Kit with Accessories 177 01 e 1 vial CliniMACS CD34 Reagent e 1 CliniMACS Tubing Set e 3x1L CliniMACS PBS EDTA Buffer e 1 Pre System Filter e 1 Luer Spike Interconnector e 1 Transfer Bag 150 mL CliniMACS CD34 Complete LS Kit 170 01 e 2 vials CliniMACS CD34 Reagent e 1 CliniMACS Tubing Set LS e 3x1L CliniMACS PBS EDTA Buffer CliniMACS CD34 Complete LS Kit with Accessories 169 01 e 2 vials CliniMACS CD34 Reagent e 1 CliniMACS Tubing Set LS e 3x1L CliniMACS PBS EDTA Buffer e 1 Pre System F
35. MACS Products D Y a In the allogeneic transplantation setting L Alyea etal 1998 Blood 91 3671 3680 CD4 FITC human 130 080 501 2 Bellucci et al 2002 Blood 15 4610 4617 C CDA T cells in donor lymphocyte infusions 3 Fowleretal 2004 Semin Oncol 31 56 67 CD4 PE human 130 091 231 Q may be capable of mounting anti tumor 4 Bernstein et al 2004 Clin Immunol III 262 274 CD4 APC human 130 091 232 dei responses concomitantly reducing the risk 3 Levineet al 2002 Nat Med 8 47 53 CD3 FITC human 130 080 401 CU 1 2 Be 6 Davis et al 2004 Mol Ther 9 160 172 kw V of GVHD and reconstituting the recipient s CD25 Biotin human 130 091 235 e immune system Anti Biotin PE 130 090 756 OI The CliniMACS System components Reagents Tubing Sets Instruments Anti Biotin APC 130 090 856 N Recently TH2 cells have been successfully deet CD8 FITC human 130 080 601 a 3 ISO 13485 certified quality system In Europe the CliniMACS System n used to support stem cell grafts components are available as CE marked medical devices In the USA the CD30 PE human 130 081 401 D CJ In addition the use of CD4 T cells may CliniMACS System components including the CliniMACS Reagents are CD14 PE human 130 091 242 be the basis for various gene therapeutic available for use only under an approved Investigational New Drug IND CD25 PE human 130 091 024 l wr application or
36. PE 130 090 756 Anti Biotin APC 130 090 856 CD30 PE human 130 081 401 CD4 FITC human 130 080 501 The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans Unless otherwise specifically indicated Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use 22 D 4 N z vA e i on D N OU ied Un UJ lt x U T cells CliniMACS CD25 Cell Separation Product Regulatory status Capacity max Availability Order no CliniMACS CD25 Reagent CE 6x10 CD25 cells Europe US 274 01 highly expressing CD25 from 40 x10 total cells CliniMACS CD25 MicroBeads For research use only 6x10 CD25 cells US CAN AUS not for use in humans highly expressing CD25 from 40 x10 total cells For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approv
37. Spain Phone 34 91 512 1290 Fax 34 91 512 12 91 macs miltenyibiotec es United Kingdom Miltenyi Biotec Ltd Almac House Church Lane Bisley Surrey GU24 9DR United Kingdom Phone 44 1483 799 800 Fax 44 1483 799 811 macs miltenyibiotec co uk 130 090 666 07
38. abeled in the Cell Preparation Bag using an antigen specific reagent After labeling the cells are washed to remove excess reagent Then the Cell Preparation Bag containing the labeled cells is connected to the Tubing Set which in turn is connected to the CliniMACS Buffer Bag and Cell Collection Bag After starting for example the enrichment program the system automatically applies the cell sample onto the selection column The sample application is followed by a series of washing steps depending on the chosen enrichment program Finally the target cells are eluted from the column The CliniMACS Plus Instrument in combination with the CliniMACS System separates large numbers of cells providing target cells with high purity and excellent yield A range of tubing sets optimized for different applications is available The CliniMACS System CliniMACS Plus Instrument CliniMACS Tubing Sets CliniMACS Reagents and CliniMACS PBS EDTA Buffer offers a flexible platform enabling the separation of many cell types as well as customized separation protocols according to specific sample requirements Unique reagents and tubing sets also allow for the transition of promising research applications in innovative cell therapy concepts Figure 1 Cell Selection Column placed in the CliniMACS Magnetic Separation Unit The CliniMACS Plus Instrument is CE marked for clinical use in Europe and is used for the separation of a variety of human cell
39. able for magnetic labeling of 10x10 CD56 cells from up to 40 x 10 total cells Please inquire about recommended device and accessories www miltenyibiotec com Applications CliniMACS CD56 Products were developed for the enrichment of NK and NKT cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System In order to generate highly purified CD56 CD3 NK cells the CliniMACS CD56 Reagent is used in combination with the CliniMACS CD3 Reagent In this approach the cellular product is first depleted of CD3 cells and then further enriched for CD56 Referenced literature NK cells have been used in haploidentical PBSC transplantation settings as donor lymphocyte infusions DLIs to explore the prevention of GVHD and early relapse of hematological malignant diseases e g AML CML Use of NK DLIs for stabilizing an impending decreasing donor chimerism in a haploidentical transplantation setting has also been published References 1 Duwendag et al 2004 20th International NK Cell Workshop Noordwijkerhout NL lyengaretal 2003 Cytotherapy 5 6 479 484 Uhareketal 2002 Onkologie 25 Suppl 4 P844 Uhareketal 2003 Onkologie 26 Suppl 5 V374 Passweg etal 2003 Onkologie 26 Suppl 5 P482 Leung etal 2004 J Immunol 172 644 650 Maillard et al 2004 8th International Symposium on DC Brugge Belgium 8 Giebel et al 2003 Blood
40. amma IFN gamma is a cytokine secreted by CD4 and CD8 memory and effector T cells upon antigenic restimulation The CliniMACS Cytokine Capture System IFN gamma is comprised of the CliniMACS IFN gamma Catchmatrix Reagent consisting of CD45 antibodies conjugated to IFN gamma specific antibodies and the CliniMACS IFN gamma Enrichment Reagent The CliniMACS IFN gamma Enrichment Reagent consists of superparamagnetic iron dextran particles conjugated to IFN gamma specific antibodies The CliniMACS IFN gamma Enrichment Reagent allows for magnetic selection of the IFN gamma secreting cells One kit is suitable for processing up to 1x10 total cells Please inquire about recommended device and accessories 25 Applications The CliniMACS Cytokine Capture System IFN gamma allows for the concomitant enrichment of viable antigen specific CD4 and CD8 IFN gamma secreting T cells Referenced literature Antigen specific CD4 and CD8 T cells can be enriched using the CliniMACS Cytokine Capture System IFN gamma T cells with specificity for CMV or Adenovirus could be expanded in vitro The adoptive transfer of antigen specific T cells may hold promise for the treatment of viral infections References Campbell 2003 Methods 31 2 150 159 Feuchtinger et a 2004 Exp Hematol 32 3 282 289 Rauseretal 2004 Blood 103 9 3565 3572 Feuchtinger et al 2005 Br J Haematol 128 503 509
41. arked components CE marked components CE marked components CE marked components For research use only not for use in humans CE marked components CE marked components CE marked components CE marked components For research use only not for use in humans CE marked components CE marked components CE marked components Complete Kit T cells CliniMACS CD3 Reagent CE CliniMACS CD3 MicroBeads For research use only not for use in humans CliniMACS CD4 Reagent CE CliniMACS CD4 MicroBeads For research use only not for use in humans CliniMACS CD8 Reagent CE CliniMACS CD8 MicroBeads For research use only not for use in humans CliniMACS CD25 Reagent CE CliniMACS CD25 MicroBeads For research use only not for use in humans CD3 CD19 combination products please see chapter Stem and progenitor cells Antigen specific T cells CliniMACS Cytokine Capture System CE IFN gamma CliniMACS Cytokine Capture System IFN gamma MicroBeads For research use only not for use in humans For availability in your country please contact your local representative 1 The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system Availability Europe CAN AUS US Europe Europe Europe Europe US Europe US Europe Europe Europe Europe US CAN AUS Europe Europe Europe Europe US US CAN AUS E
42. ation Bag tube 250 Cell Differentiation Bag tube 500 Cell Differentiation Bag 6 ports 100 Cell Differentiation Bag 6 ports 250 Cell Differentiation Bag 6 ports 500 Pre System Filter Luer Spike Interconnector Sampling Site Coupler Transfer Set Coupler Needle Transfer Set Coupler Coupler Transfer Set Needle Needle Transfer Bag 150 mL Transfer Bag 600 mL Transfer Bag 1000 mL Transfer Bag 600 mL with 8 couplers Regulatory status CE CE For research use only For research use only CEP CE CE CE CE CE For research use only For research use only For research use only For research use only For research use only For research use only CE CE CE CE CE CE CE CE CE CE For availability in your country please contact your local representative 1 The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system Availability Europe Europe US CAN AUS US CAN AUS Europe Europe Europe Europe Europe Europe US CAN AUS US CAN AUS US CAN AUS US CAN AUS US CAN AUS US CAN AUS Europe Europe Europe Europe Europe Europe Europe Europe Europe Europe NEW NEW NEW NEW NEW NEW NEW NEW Order no 200 074 301 200 074 302 130 074 351 130 074 352 200 074 101 200 074 102 200 074 103 200 074 201 200 074 202 200 074 203 130 074 151 130 074 152
43. c T cells Possible scenarios may also include autoimmune diseases such as rheumatoid arthritis and others www miltenyibiotec com It has been shown that optimal T cell immunity requires both CD4 helper T cells and CD8 cytotoxic T cells The CliniMACS Cytokine Capture System IFN gamma enables the enrichment of viable antigen specific CD4 and antigen specific CDS T cells based on the cytokines they secrete The CliniMACS Cytokine Capture System IFN gamma offers unique reagents for clinical scale enrichment of antigen specific T cells specifically developed for use exclusively on the CliniMACS System Those cell preparations are the prerequisite for detailed analyses on the frequency and phenotype of the key players in a given immune response Since the cells are viable after enrichment subsequent in vitro steps such as expansion of the antigen specific cells can be performed Such an expansion step can also be performed in the bag to provide a greater degree of assurance of sterility The sensitivity and reliability of the assays have been demonstrated in a large panel of high level scientific publications These describe a variety of research applications from oncology or virology to autoimmune diseases Using the CliniMACS Cytokine Capture System IFN gamma the enrichment can be performed directly in the bag starting from up to 1 x10 total cells As for all CliniMACS applications the en
44. c cells CliniMACS CD14 Reagent CliniMACS CD14 Complete Kit CliniMACS CD14 MicroBeads CliniMACS CD1c BDCA 1 Biotin CliniMACS CD1c BDCA 1 CD19 Complete Kit CliniMACS CD1c BDCA 1 Biotin for Research Use CliniMACS CD304 BDCA 4 MicroBeads Flexible labeling system CliniMACS Anti Biotin Reagent CliniMACS Anti Biotin MicroBeads CliniMACS Biotinylation Kit 500 CliniMACS Biotinylation Kit 500 for Research Use CliniMACS Buffers CliniMACS PBS EDTA Buffer CliniMACS PBS EDTA Buffer for Research Use Regulatory status CE CE marked components CE marked components For research use only not for use in humans CE For research use only not for use in humans EE CE marked components For research use only not for use in humans CE CE marked component For research use only not for use in humans For research use only not for use in humans CE For research use only not for use in humans GE For research use only not for use in humans CE For research use only not for use in humans For availability in your country please contact your local representative Availability Europe US Europe Europe US CAN AUS Europe US US CAN AUS Europe US Europe US CAN AUS Europe US Europe US CAN AUS Worldwide Europe US US CAN AUS Europe US US CAN AUS Europe CAN AUS US US Order no NEW NEW NEW 271 01 704 01 740 04 194 01
45. cal representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Description E A Before enrichment B After enrichment CD133 is expressed on immature hematopoietic stem and progenitor cells but is not found on mature blood cells In contrast to the CD34 antigen CD133 is amp amp not expressed by late progenitors such as S S pre B cells CFU E and CFU G The stem cell v bw marker CD133 was formerly known as AC133 CliniMACS CD133 Products consist of CD133 2 PE CD133 2 PE superparamagnetic iron dextran particles Figure 1 Flow cytometric analysis of CD133 enriched cells from directly conjugated to CD133 antibodies a mobilized leukapheresis product using the CliniMACS CD133 System One vial contains 7 5 mL sterile non pyrogenic solution suitable for magnetic labeling of up to 0 6 x10 CD133 cells from up to 60x10 total cells Please inquire about recommended device A Before enrichment B After enrichment and accessories CD34 APC CD34 APC Applications CliniMACS CD133 AC133 Products were developed for the enrichment of mu CD133 cells from human heterogeneous CD133 2 PE CD133 2 PE hematologic cell populations in Figure 2 Flow cytometric analysis of CD133 enriched stem cells combination with the CliniMACS System from a bone
46. cells For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Description A Before enrichment B After enrichment CD4 is an accessory molecule in the e VERE oe recognition of foreign antigens in association with MHC class Il antigens by T cells T helper cells and to a lower degree monocytes and dendritic cells express CD4 CD14 PE CD14 PE The CliniMACS CD4 Products consist of superparamagnetic iron dextran particles OA ae A directly conjugated to CD4 antibodies CD4 FITC CD4 FITC Figure 1 Flow cytometric analysis of CD4 enriched cells using the CliniMACS CD4 System One vial contains 7 5 mL sterile non pyrogenic solution suitable for magnetic labeling of up to 12x10 CD4 cells from up to 40x10 total cells A Before depletion B After depletion Please inquire about recommended device and accessories ss C h a O U Applications CliniMACS CD4 Products were developed for the depletion or enrichment of aa n CD4 PE CD4 PE CDA cells from human heterogeneous Figure 2 Flow cytometric analysis of CD4 depleted cells using the hematologic cell populations in CliniMACS CD4 System combination with the CliniMACS System Referenced literature References Ld Related
47. certified quality system In Europe the CliniMACS System components are available as D 4 N Z Y a e Fu i e D N OU J Un UW lt x U predicts nae been developed iu me 500 ug monoclonal antibody CE marked medical devices In the USA the CliniMACS System components biotinylation of monoclonal antibodies including the CliniMACS Reagents are available for use only under an approved for further magnetic cell enrichment Please check in advance whether the Investigational New Drug IND application or Investigational Device Exemption E e IDE from human heterogenerous antibody is suitable for biotinylation E hematologic cell populations using the magnetic labeling and cell separation CliniMACS MicroBeads are for research use only and not for use in CliniMACS System using the CliniMACS System humans Unless otherwise specifically indicated Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use 35 www miltenyibiotec com CliniMACS Buffers CliniMACS PBS EDTA Buffer Product CliniMACS PBS EDTA Buffer Content Regulatory status 3x1L plastic bags CE Order no 700 25 Availability Europe CAN AUS US For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New D
48. e 187 01 For availability in your country please contact your local representative Description Adapter with spike and female luer connector suitable for the attachment of transfer bags to these CliniMACS Tubing Sets Sampling Site Coupler Product Sampling Site Coupler Sterilized non pyrogenic single packed Please inquire about recommended device and accessories Content Regulatory status 5 Couplers CE Figure 1 The Luer Spike Interconnector Availability Order no Europe 189 01 For availability in your country please contact your local representative Description Injection port suitable for cell labeling procedures e g for taking samples Sampling Site Coupler is suitable for centrifugation connected to transfer bags www miltenyibiotec com Sterilized single packed Please inquire about recommended device and accessories Figure 1 The Sampling Site Coupler 40 D 4 N as vA e FN i on D NN OU bg Un UJ et U Accessories Transfer Set Coupler Needle Product Content Regulatory status Availability Order no Transfer Set Coupler Needle 5 Transfer Sets CE Europe 185 01 For availability in your country please contact your local representative Description Sterilized non pyrogenic single packed Plasma transfer set with coupler and puncture needle Please inquire about recommended device and accessories This transfer s
49. e for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Description Before depletion After depletion The CliniMACS Anti Biotin Products consist of i superparamagnetic iron dextran particles direct ly conjugated to Biotin specific antibodies a 10 01 One vial contains 7 5 mL sterile non pyrogenic solution suitable for magnetic labeling of CD3 CD14 CD15 PE CD3 CD14 CD15 PE target cells from up to 40 x10 total cells Please inquire about recommended device TE CD20 FITC CD20 FITC and accessories Figure 1 Flow cytometric analysis of CD19 depleted cells using the CliniMACS um Anti Biotin System in combination with CD19 biotinylated antibody Applications The CliniMACS Anti Biotin Products were developed for the enrichment or depletion of target cells labeled with a biotinylated The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE primary antibody or ligand Anti Biotin MicroBead Ld Related CliniMACS Products CliniMACS CD1c BDCA 1 Bio
50. e three compartments to allow for expandable volumes of up to 100 mL The bag are individually packed sterile and tested for endotoxins Applications Cell Expansion Bags are intended for the in vitro cultivation and expansion of human cells from heterogeneous haematologic cell populations e g for the expansion of antigen specific T cells www miltenyibiotec com Female luer lock Male luer lock cap Chamber Chamber Il Chamber Ill Connection strip Sample identification tag Figure 1 Cell Expansion Bag tube with two seals for expandable culture volumes Needleless access connector Chamber Chamber Il Chamber Ill Connection strip o Sample identification tag Figure 2 Cell Expansion Bag 6 ports with two seals for expandable culture volumes and six needleless access connectors 38 D 4 N z vA e i on D N OU ied Un UJ lt x U D 4 N Z Y a e i Q D Ta OU Un UI lt x U Accessories Cell Differentiation Bags Product Cell Differentiation Bag tube 100 Content 5 Bags Regulatory status CE Capacity 100 mL Availability Europe Order no 200 074 101 Cell Differentiation Bag tube 250 5 Bags CE 250 mL Europe 200 074 102 Cell Differentiation Bag tube 500 2 Bags CE 500 mL Europe 200 074 103 C
51. ecially for allogeneic lymphoproliferative disease in allogeneic grafts CD34 enrichment of progenitor transplantation settings This has been References cells in the autologous setting may suggested in the HLA identical setting 1 Elmaagacli et al 2003 Blood 101 2 446 453 NE 12 34 2 Urbano Ispizua et al 2001 Bone Marrow Transplant 28 349 354 be used for removing contaminating with related as well as unrelated 3 Bornhaeuseret al 2000 Haematologica 85 839 847 tumor cells from the graft purging donors It is thought to be crucial in the 4 Langetal 2003 Blood 101 1630 1636 5 Handgretinger et al 2003 Pediatr Transplant 7 Suppl 3 51 55 6 Aversa etal 2004 Springer Semin Immunopathol 26 1 2 155 68 n 32 n gt 500 n 293 n 136 n 30 7 Flohr et al 2002 Bone Marrow Transplant 29 769 775 8 Handgretinger et al 2002 Bone Marrow Transplant 29 731 736 Purity CD34 97 2 95 99 97 5 90 96 9 Snowden etal 2004 J Rheumatol 31 482 488 11 Carreras et al 2003 Haematologica 88 306 14 CD3 log depletion 4 6 25 4 6 4 6 5 12 Rosen et al 2000 Arthritis Research 2 327 336 CD19log depletion nd lt 0 5 nd 3 2 3 2 13 Handgretinger et al 2003 Pediatr Transplant 7 Suppl 3 51 55 14 Lang et al 2004 ISCT Dublin Miltenyi Biotec Satellite Symposium Table 1 Clini MACS CD34 Enrichment results from PBSCs of allogeneic donors nd not determined 15 Falzetti et al 2002
52. ed Investigational New Drug IND application or Investigational Device Exemption IDE Description A Before enrichment B After enrichment The CD25 antigen the low affinity interleukin 2 receptor alpha chain IL 2Ra is expressed on activated T and B cells In addition CD25 is highly expressed on naturally occuring CD25 CD4 regulatory T cells CD25 Biotin Anti Biotin PE CD25 Biotin Anti Biotin PE The CliniMACS CD25 Products consist of superparamagnetic iron dextran particles directly conjugated to CD25 antibodies CD4 FITC CD4 FITC Figure 1 Flow cytometric analysis of CD25 enriched cells using the CliniMACS CD25 System One vial contains 7 5 mL sterile non Analysis of the content of CD25 CD4 regulatory T cells For flow cytometric analysis a pyrogenic solution suitable for magnetic specific electronic window is defined Regulatory T cells have been described as CD4 9 x T cells which highly express CD25 The expression of CD4 is slightly reduced as compared labeling of 6x10 CD25 cells highly to conventional CD4 T helper cells expressing CD25 from up to 40 x10 total cells A Before depletion B After depletion Please inquire about recommended device and accessories Applications CliniMACS CD25 Products were developed for the enrichment or depletion of CD25 cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System CD3 HITC CD3 HTC CD2
53. ell Differentiation Bag 6 ports 100 5 Bags CE 100 mL Europe 200 074 201 Cell Differentiation Bag 6 ports 250 5 Bags CE 250mL Europe 200 074 202 Cell Differentiation Bag 6 ports 500 2 Bags CE 500 mL Europe 200 074 203 Cell Differentiation Bag tube 100 5 Bags For research use only 100 mL US CAN AUS 130 074 151 Cell Differentiation Bag tube 250 5 Bags For research use only 250mL US CAN AUS 130 074 152 Cell Differentiation Bag tube 500 2 Bags For research use only 500 mL US CAN AUS 130 074 153 Cell Differentiation Bag 6 ports 100 5 Bags For research use only 100 mL US CAN AUS 130 074 251 Cell Differentiation Bag 6 ports 250 5 Bags For research use only 250mL US CAN AUS 130 074 252 Cell Differentiation Bag 6 ports 500 2 Bags For research use only 500 mL US CAN AUS 130 074 253 For availability in your country please contact your local representative 1 The Cell Differentiation Bags are manufactured and controlled under an ISO 13485 certified quality system These products are available in Europe as CE marked medical devices 2 Manufactured by Miltenyi Biotec GmbH under an ISO 9001 certified quality system Description Cell Differentiation Bags are gas permeable and transparent for microscopy They are available for three diff
54. er CD14 enrichment MoDCs have been used in many of these clinical trials and are well characterized In vitro experiments have demonstrated that MoDCs and DCs derived from CD34 precursor cells are able to present antigens and efficiently induce a specific immune response dominated by effector T cells However in clinical studies using DCs clinical responses have been lacking in most patients treated It is thought that other components of the immune system including NK cells myeloid or plasmacytoid blood DCs PDCs as well as regulatory T cells may be necessary for a clinical response Recent findings support a role for regulatory T cells in limiting the tumor specific immune response induced by DCs It has been demonstrated that CD1c BDCA 1 positive myeloid DCs display a strong costimulatory and cross presenting capacity Plasmacytoid dendritic cells PDCs are the most potent Type I IFN producing cells identified so far Interferon alpha 2a is used as pharmaceutical drug in indications such as malignant melanoma and other malignancies Thus the local application of PDCs could become a promising tool in enhanced vaccine strategies Recent developments will soon enable the use of blood myeloid DCs which are CD1c BDCA 1 positive or the use of CD304 BDCA 4 positive PDCs The possibility to enrich both cell types will allow for new enhanced DC vaccine strategies Because these DC subsets are derived direc
55. erent culture volumes 100 mL 250 mL and 500mL The bag are individually packed sterile and tested for endotoxins Applications Cell Differentiation Bagsare intended for the in vitro cultivation and expansion of cells from heterogeneous haematologic cell populations e g for the generation of dendritic cells from CD14 enriched monocytes 59 Female luer lock Male luer lock cap Cell culture chamber Connection strip Figure 1 Cell Differentiation Bag tube Sample identification tag Cell culture chamber Connection strip 7 f xc Sample identification tag Figure 2 Cell Differentiation Bag 6 ports with six needleless access connectors ww w miltenyibiotec com Accessories Pre System Filter Product Pre System Filter Content 5 Filters CE Regulatory status Availability Order no Europe 181 01 For availability in your country please contact your local representative Description Pre System Filter for cell separation Blood transfusion filter 40 micron pore width A Pre System Filter should be used with all CliniMACS Tubing Sets in order to retain cell aggregates Luer Spike Interconnector Product Luer Spike Interconnector Sterilized non pyrogenic fluid pathway single packed Please inquire about recommended device and accessories Content Regulatory status 5 Interconnectors CE Figure 1 The Pre System Filter Availability Order no Europ
56. es Chile Rm 2301 No 319 Xianxia Rd Fareast International Plaza A Shanghai 200051 P R China Unit 916 Silver Tower 2 Dong San Huan North Road Chao Yang District Beijing 100027 P R China Calle 37 416 51 Bogota DC Colombia Savska cesta 141 10000 Zagreb Croatia Apollon Tower 15 A3 64 L Riankour str 11523 Athens Greece Zl tovska 2211 911 01 Tren n Slovakia C La Tierra 388 E8 11B y Av de los Shyris 17 17 1413 Casilla Ecuador Al Saif Medical Centre Ibn Khaldoun Street Amman Jordan Phone 454 11 4572 8458 Fax 454 11 4572 8458 Phone 61 02 8877 7400 Fax 61 02 9889 5044 Phone 49 2204 8306 0 Fax 49 2204 85197 Phone 962 6 4655 166 Fax 962 6 4655 167 Phone 375 172 67 00 25 Fax 375 172 67 74 32 Phone Belgium 0800 94016 Fax Belgium 0800 99626 Phone 55 11 3665 1090 Fax 55 11 3665 1096 Phone 30 210 6996 191 Fax 30 210 6920 210 Phone 1 530 888 88 71 Fax 1 530 888 89 25 Phone 56 2 334 9282 Fax 56 2 334 1136 Phone 86 21 6235 1005 Fax 86 21 6235 0953 Phone 86 10 6410 7101 Fax 86 10 6410 7102 Phone 57 1 285 5053 Fax 457 1 285 1538 Phone 385 1 6191 580 Fax 385 16191 608 Phone 30 210 6996 191 Fax 30 210 6920 210 Phone 421 32 6524 998 Fax 421 32 6525 792 Phone 593 22 267 554 Fax 593 22 433 550 Phone 962 6 4655 166 Fax 962 6 4655 167 In the United States CliniMACS products for clinical use are available only under an appro
57. et can be used for connecting the CliniMACS PBS EDTA Buffer bag to the cell preparation bag Figure 1 The Transfer Set Coupler Needle Transfer Set Coupler Coupler Product Content Regulatory status Availability Order no Transfer Set Coupler Coupler 5 Transfer Sets CE Europe 186 01 For availability in your country please contact your local representative Description Sterilized non pyrogenic single packed Plasma transfer set with two couplers Please inquire about recommended device This transfer set can be used for connecting and accessories the CliniMACS PBS EDTA Buffer bag to the cell preparation bag or to connect two buffer bags Figure 1 The Transfer Set Coupler Coupler Transfer Set Needle Needle Product Content Regulatory status Availability Order no Transfer Set Needle Needle 5 Transfer Sets CE Europe 188 01 For availability in your country please contact your local representative Description Sterilized non pyrogenic single packed Plasma transfer set with two needles Please inquire about recommended device This transfer set can be used for connecting and accessories the CliniMACS PBS EDTA Buffer Bag to the Cell Preparation Bag Figure 1 The Transfer Set Needle Needle D 4 N Z Y a e Fu i e D N OU W Un UW lt x U 41 ww w miltenyibiotec com Accessories Transfer Bags 150 mL 600 mL and 1000 mL Product Content Regulatory statu
58. for controlled flow of buffer or cell suspension throughout the procedure Display guides user through set up and shows automatic system operations Peristaltic pump controls flow through tubing set Cell Collection Bag for target cells Bag compartment for wash and non target cell fraction www miltenyibiotec com D Un as Y e ES on D NN OU LO Un UI lt U D 4 N Z Y a e i Q D N OU Un UW lt x U CliniMACS Plus Instrument CliniMACS Plus Instrument Product CliniMACS Plus Instrument Regulatory status CE Europe CAN AUS US 151 01 Availability Order no For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Description The CliniMACS Plus Instrument is an enhanced version of the CliniMACS Cell Selection Device While the basic CliniMACS Instrument was designed to enrich stem and progenitor cells the CliniMACS Plus Instrument provides an open platform technology enabling additional isolation strategies for many cell types such as monocytes dendritic cells NK cells T cells and B cells see chapter CliniMACS Reagents or call for application updates The combination
59. g mixed chimerism or relapse in the above men tioned setting Safety and feasibility of this approach was recently reviewed References 1 K rre 2002 Science 295 2029 2031 Ruggeri et al 2002 Science 295 2097 2100 Giebel et al 2003 Blood 102 814 819 Elmaagacli et al 2004 Onkologie 27 Suppl 3 0194 Uharek et al 2003 Onkologie 26 Suppl 5 V374 Passweg et al 2003 Onkologie 26 Suppl 5 P482 Passweg et al 2004 Leukemia 18 11 1835 1838 lyengar et al 2003 Cytotherapy 5 6 479 484 Duwendag et al 2004 20th International NK cell Workshop Noordwijkerhout NL 10 Passweg et al 2005 BMT 35 637 643 Oo CON AD NT SW Fi 2 NK mediated immune surveillance autologous O healthy cell l7 7 KIR killer cell immunoglobulin like receptor HK NCR natural cytotoxicity receptor NK mediated lysis through KIR mismatch situation missing self autologous allogeneic NK cell NK cell tumor tumor cell cell apoptotic cell apoptotic cell E MHC class NCR ligand Figure 1 Defense mechanisms of natural killer cells Specific Lysis ui o post IL 2 IL 12 post CD56 enrichment untreated PBMCs Target K562 8B 5 1 10 1 20 1 Effector Target Figure 2 Activation of CD56 CD3 NK cells upon treatment with IL 2 IL 12 Courtesy of Dr Uharek Berlin Germany
60. ibiotec co uk www miltenyibiotec com macs miltenyibiotec com www miltenyibiotec com miguelbio cantv net www biochrom com ve macs miltenyibiotec de www miltenyibiotec com 46 N em O dud Q dud Ed C CliniMACS Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System and Reagents are available as CE marked medical devices In the USA CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans Unless otherwise specifically indicated Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use MACS and CliniMACS are registered trademarks of Miltenyi Biotec GmbH Printed in May 2008 O 2008 Miltenyi Biotec GmbH Miltenyi Biotec Germany Austria Switzerland Miltenyi Biotec GmbH Friedrich Ebert Strafe 68 51429 Bergisch Gladbach Germany Phone 49 2204 8306 0 Fax 49 2204 85197 macs miltenyibiotec de USA Canada Miltenyi Biotec Inc 12740 Earhart Avenue Auburn CA 95602 USA Phone 800 FOR MACS Phone 1 530 888 8871 Fax 1 530 888 8925 macs miltenyibiotec com www miltenyibiotec com Oy Australia Miltenyi Biotec Aust
61. ide 167 01 for Research Use not for use in humans For availability in your country please contact your local representative 1 Manufactured by Miltenyi Biotec GmbH under an ISO 9001 certified quality system Description CliniMACS Tubing Sets 600 and 150 for Research Use are ideal tools for pre clinical cell separations on the CliniMACS Platform The CliniMACS Tubing Sets for Research Use with reduced tubing geometry consist of a selection column without a pre column One package unit contains five separately sealed tubing sets for single use CliniMACS Tubing Set 600 for Research Use 166 01 The CliniMACS Tubing Set 600 for Research Use was designed for the separation from up to 20x10 total cells CliniMACS Tubing Set 150 for Research Use 167 01 The CliniMACS Tubing Set 150 for Research Use was designed for the separation from up to 10x10 total cells Please inquire about recommended device and accessories Figure 1 Clini MACS Tubing Set 600 for Research Figure 2 CliniMACS Tubing Set 150 for Research Use Use Applications The CliniMACS Tubing Sets 600 and 150 for Research Use can be utilized for various pre clinical separations The system allows for large scale sterile cell separation The cells can be used for example for animal models cell culture assays or other research related applications D 4 N z vA e i on D N OU ied Un UJ lt x U www
62. ilter 1 Luer Spike Interconnector e 1 Transfer Bag 150 mL Related MACS Products CD34 FITC human 130 081 001 CD34 PE human 130 081 002 CD34 APC human 130 090 954 CD133 2 293C3 PE human 130 090 853 CD133 2 293C3 APC human 130 090 854 CD45 FITC human 130 080 202 The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans Unless otherwise specifically indicated Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use 14 D 4 N z vA e i on D N OU bg Un UJ lt x U Stem and progenitor cells CliniMACS CD133 AC133 Enrichment Background The CD133 antigen has been identified as a stem cell marker CD133 is specifically expressed on an immature subset of CD34 cells on circulating endothelial progenitor cells as well as on a CD34 stem cell subset see figure 1 CD133 is a marker for very early hematopoietic stem cells with high
63. ing both beneficial and harmful immune responses In the transplant setting graft versus leukemia GVL effects and graft versus host diseases GVHD are in a large part conveyed by donor T lymphocytes as part of the unfolding adaptive immune response New immunotherapy strategies have evolved designed to separate GVL from GVHD as well as to boost GVL and reduce GVHD The CliniMACS System together with the broadened CliniMACS T Cell Product portfolio allows for enrichment or depletion of different T cell subsets providing the basis for a variety of different applications The CliniMACS CD3 Reagent was developed for the depletion of T cells from unmobilized as well as mobilized leukapheresis products The rationale for this application is that the depletion of T cells may lower the risk of GVHD Combined depletion of T and B cells from MHC class presentation CD8 CD25 Ag specific cel Dendritic cell the graft using CliniMACS CD3 and CD19 Reagents leaves stem and progenitor cells and in addition provides a graft which contains NK cells Enrichment of NK cells can also be achieved using the CliniMACS CD56 Reagent after prior depletion of T cells with the CliniMACS CD3 Reagent For certain oncological settings preliminary data suggest that T cells in a graft or as a donor lymphocyte infusion DLI may be beneficial In these settings a CD4 enrichment or CD8 depletion may be desired CD4 T cells not only
64. ion or Investigational Device Exemption IDE Description As a B cell lineage marker CD19 is expressed from the early pro B cell stage to the B cell lymphoblast stage however CD19 is down regulated as B cells mature to plasma cells The CD19 antigen is also expressed on most malignant B cells and on a subset of follicular dendritic cells The CliniMACS CD19 Products consist of superparamagnetic iron dextran particles directly conjugated to CD19 antibodies One vial contains 7 5 mL sterile non pyrogenic solution suitable for magnetic labeling of up to 5 x10 CD19 cells from up to 40x10 total cells Please inquire about recommended device and accessories Applications CliniMACS CD19 Products were developed for depletion of CD19 B cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System The depletion of CD19 cells can be performed to remove unwanted malignant or potentially EBV infected B cells from cellular products References 1 Barfield et al 2004 Cytotherapy 6 1 6 www miltenyibiotec com A Before depletion B After depletion CD3 CD14 CD15 PE CD3 CD14 CD15 PE CD19 APC CD19 APC Figure 1 Flow cytometric analysis of CD19 depleted B cells from leukapheresis product using the CliniMACS CD19 System gl Related CliniMACS Products CliniMACS CD3 CD19 Reagent Combination 704 00 CliniMACS CD1c BDCA 1 Biotin 277 01 1 Notavailable
65. itic cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System After labeling of target cells with the CliniMACS CD1c BDCA 1 Biotin the CliniMACS Anti Biotin Reagent is used for the magnetic enrichment of CD1c BDCA 1 cells from the cellular product A CD19 B cell depletion is recommended prior to the enrichment of CD1c BDCA 1 cells 33 A Before enrichment 0 61 CD20 APC CD20 APC dern CD1c BDCA 1 PE B After CD19 depletion Flow cytometric analysis of CD1c BDCA 1 cell enrichment C After CD19 depletion and CD1c BDCA 1 enrichment 93 2 1 34 CD20 APC CD1c BDCA 1 PE CD1c BDCA 1 PE Figure 1 Flow cytometric analysis of CD19 depleted cells B followed by the analysis of CD1c BDCA 1 enriched cells C using the CliniMACS CD19 and CliniMACS CD1c BDCA 1 Biotin System in combination Kit components not available in the US CliniMACS CD1c BDCA 1 CD19 Complete Kit 740 03 1 vial CliniMACS CD1c Anti BDCA 1 Biotin 1 vial CliniMACS CD19 Reagent 1 vial CliniMACS Anti Biotin Reagent e 1 CliniMACS Tubing Set e 1 CliniMACS Tubing Set LS e 3 units 3x1L CliniMACS PBS EDTA Buffer References Dzionek A et al 2000 J Immunol 165 6037 6046 2 Dzionek A et al 2002 Hum Immunol 63 12 1133 1148 3 Piechaczek Cet al 2002 7th International Symposium on Dendritic Cells Bamberg Germany P197
66. liniMACS System The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans D 4 N Z Y a e i Q D N OU Un UW lt x U 9 www miltenyibiotec com CliniMACS Tubing Sets CliniMACS Tubing Sets for Research Use Product Components Regulatory status Capacity max Availability Order no CliniMACS Tubing Set 1 Tubing Set For research use only 60x10 total cells US 165 01 for Research Use not for use in humans CliniMACS Tubing Set LS 1 Tubing Set For research use only 120 x 10 total cells US 168 01 for Research Use not for use in humans For availability in your country please contact your local representative 1 Capacity max of labeled cells depends on the software program used 2 Manufactured by Miltenyi Biotec GmbH under an ISO 9001 certified quality system Description CliniMACS Tubing Sets for Research Use consist of pre assembled tubing including a pre column and a selection column The fluid
67. llite Symposium EAS 5 4 Fritsch et al 2004 ISCT Dublin Ireland 192 Remaining B Sole 0 1 0 005 nd Eo 5 Preijers et al 2004 Bone Marrow CD3 log depletion 3 4 3 9 3 7 3 Transplant 33 Suppl 1 93 CD19 log depletion 2 2 nd 3 7 nd Table 1 CliniMACS CD3 CD19 Depletion results from allogeneic settings nd2not determined References 1 3 5 1 Not available in the United States D Un Z N a e rum i C D N OU LO Un UI lt U 1 7 www miltenyibiotec com Stem and progenitor cells CliniMACS CD3 CD19 Depletion Product CliniMACS CD3 CD19 Reagent Combination CliniMACS CD3 CD19 Complete Kit CliniMACS CD3 CD19 Large Scale Complete Kit Order no 704 00 Availability Capacity max 5 x10 CD19 cells and 15 x10 CD3 cells from 40 x10 total cells 5 x10 CD19 cells and 15 x10 CD3 cells from 40 x10 total cells 10x10 CD19 cells and 30 x10 CD3 cells from 80 x10 total cells Regulatory status CE marked components CE marked components CE marked components Europe Furope 740 01 Furope 740 02 For availability in your country please contact your local representative Description The CliniMACS CD3 CD19 Products consist of superparamagnetic iron dextran particles directly conjugated to CD3 and CD19 antibodies Each vial contains 7 5 mL sterile non pyrogenic solution suitable for magnetic labeling of up to 15x10 CD3 cells and
68. m 40 x10 total cells For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Description A Before depletion B After depletion CD3 is expressed on all T cells and is UMS associated with the T cell receptor a a Approximately 70 8096 of human peripheral blood lymphocytes and x ma eam gt ae 65 85 of thymocytes are CD3 9 9 CliniMACS CD3 Products consist S 5 of superparamagnetic iron dextran T CIN PESE particles directly conjugated to CD3 CD3 FITC CD3 FITC antibodies Figure 1 Flow cytometric analysis of CD3 depleted cells from a leukapheresis product using the CliniMACS CD3 System One vial contains 7 5 mL sterile non pyrogenic solution suitable for magnetic labeling of up to 15x10 CD3 cells from Ld Related CliniMACS Products a CliniMACS CD19 Reagent 179 01 up to 40 x10 total cells CliniMACS CD56 Reagent 271 01 TA CliniMACS CD3 CD19 Please inquire about recommended Reagent Combination 704 00 device and accessories 1 Not available in the US Applications PP c Related MACS Products CliniMACS T Cell CD3 Products were CD14 PE human 130 091 242 developed for the depletion of unwanted CD15 PE human 130 091 375 T cells from human heterogeneous
69. marrow aspirate using the CliniMACS CD133 System Referenced literature References CD133 enrichment of progenitor cells is to passively remove tumor cells 1 Bitan etal 2005 Exp Hematol 33 713 718 performed to provide an allogeneic stem from the graft purging EE n n 3 Peled et al 2004 Cytotherapy 6 344 355 cell graft highly purified for CD133 cells In addition stem cells enriched 4 Lang et al 2004 Brit J Haematol 124 72 79 and depleted of unwanted cells for the CD133 antigen are being 5 Lang etal 2004 Bone Marrow Transplant 33 1 879 880 In autologous transplantation CD133 explored for use in regenerative Ga ordan eta 005 Sone Maron Tiangplanit 41 17522 l _ Gas 7 Koehl et al 2002 Bone Marrow Transplant 29 927 930 progenitor cells can be enriched in order medicine e g cardiac diseases 8 Pompilio etal 2004 Ann Thorac Surg 78 5 1808 1812 9 Klein etal 2004 The Heart Surgery Forum Vol 7 Issue 5 10 Ghodsizad et al 2004 Cytotherapy 6 5 523 526 11 Stamm et al 2004 Thorac Cardiovasc Surg 52 3 152 158 12 Stamm et al 2003 Lancet 361 9351 45 46 D 4 N as vA e i SS D N OU M Un UW lt x E U www miltenyibiotec com 1 6 Stem and progenitor cells Kit components not available in the US CliniMACS CD133 Complete LS Kit gl Related MACS Products CliniMACS CD133 Complete Kit 197 01
70. nst viral infections and solid tumors On both malignant and virally infected cells a multiplicity of so called danger signals can be up regulated These signals can be specifically recognized by NK cells enabling these cells to become activated and eventually lyse the potentially harmful target cell It is the balance between stimulating and inhibiting signals which determines whether or not the NK cells will lyse their target cells More recently NK cells have been specifically associated with the induction of graft versus leukemia GVL effects in hematopoietic malignant diseases in murine models and some retrospective analyses in the human Based on these data clinical studies were initiated to investigate the safety and feasibility of this approach in a hap loidentical transplant setting for hemato logic malignant disorders The NK cells were enriched from leukapheresis prod ucts and given as donor lymphocyte infusions DLI at various time points post transplant One important reason NK DLI has been used instead of an unmanipu lated DLI was the observation that NK cells may induce a GVL effect without inducing graft versus host disease GVHD the latter being a serious complication of unmanipulated DLIs in general It has been theorized that a KIR mismatch situation in the GVH direction may enable NK cells to lyse malignant target cells in order to exert GVL effects This effect may be used to revert impendin
71. o the LPS receptor complex and monocytes strongly express the antigen The CliniMACS CD14 Products consist of superparamagnetic iron dextran particles directly conjugated to CD14 antibodies One vial contains 7 5 mL sterile non pyrogenic solution suitable for magnetic labeling of up to 4x10 CD14 monocytes in 20x10 total cells Please inquire about recommended device and accessories Applications CliniMACS CD14 Products were developed for the enrichment of CD14 cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System The enriched cells can be used for the subsequent generation of human monocyte derived dendritic cells MoDCs www miltenyibiotec com A Before enrichment CD14 FITC CD14 FITC CD15 PE B After enrichment CD15 PE Figure 1 Flow cytometric analysis of CD14 enriched cells using the CliniMACS CD14 System Referenced literature MoDCs are currently being used in clinical trials which mainly target malignant diseases such as solid tumors and hematologic malignancies References 1 Campbell et al 2005 Methods in Molecular Medicine 109 5 55 69 Babatz et al 2003 J Hematother Stem Cell Res 12 5 515 523 Motta etal 2003 Br J Hematol 121 2 240 250 Meyer Wentrup et al 2003 J Hematother Stem Cell Res 12 3 289 299 5 Sorg et al 2003 J Immunother 26 4 374 383 6 Padley etal
72. on Tubing Set for Research Use 1 Tubing Set 40 x 10 labeled cells from 120 x 10 total cells For research use only US CAN AUS not for use in humans 266 01 For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE 2 Manufactured by Miltenyi Biotec GmbH under an ISO 9001 certified quality system Description CliniMACS Depletion Tubing Sets contain tubing with a pre assembled Cell Collection Bag Reapplication Bag Non Target Cell Bag and Buffer Waste Bag The fluid path of the tubing sets is sterile and non pyrogenic One package unit contains one sealed tubing set for single use CliniMACS Depletion Tubing Set 261 01 The CliniMACS Depletion Tubing Set was designed for the depletion of up to 40x10 labeled cells from up to 120 x10 total cells CliniMACS Depletion Tubing Set for Research Use 266 01 The CliniMACS Depletion Tubing Set for Research Use was designed for the depletion of up to 40 x10 labeled cells from up to 120 x 10 total cells Please inquire about recommended device and accessories The CliniMACS Plus Instrument with Software Version 2 40 or higher is required 11 Applications The CliniMACS Depletion Tubing Set is specifically designed for
73. path of the tubing sets is sterile and non pyrogenic One package unit contains one sealed tubing set for single use CliniMACS Tubing Set for Research Use 165 01 The CliniMACS Tubing Set was designed for the separation of cells from up to 60x10 total cells CliniMACS Tubing Set LS for Research Use 168 01 The CliniMACS Tubing Set LS was designed for the separation of cells from up to 120 x10 total cells Please inquire about recommended device and accessories Figure 1 Schematic illustration of the CliniMACS Figure 2 Schematic illustration of the CliniMACS Tubing Set for Research Use containing a pre Tubing Set LS for Research Use containing a pre Applications column and a selection column column and a selection column The CliniMACS Tubing Sets for Research Use were developed for the enrichment or depletion of cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System D 4 N z vA e i on D N OU ied Un UJ lt x U www miltenyibiotec com 1 A D 4 N Z Y a e i ge Q D TA OU Un UJ lt x U CliniMACS Tubing Sets CliniMACS Depletion Tubing Sets Product CliniMACS Depletion Components Regulatory status 1 Tubing Set CE Capacity max Availability Order no 40 x 10 labeled cells Europe US 261 01 Tubing Set from 120 x 10 total cells CliniMACS Depleti
74. pressed on involved in cell adhesion and is thought to iron dextran particles directly human hematopoietic stem and progenitor function as a signaling molecule conjugated to CD34 antibodies D N Z UD a e i C D N D J Un U lt U 1 3 www miltenyibiotec com Stem and progenitor cells One vial contains 7 5 mL sterile non pyrogenic solution suitable for magnetic labeling of up to 0 6 x 10 CD34 cells from up to 60 x10 total cells Please inquire about recommended device and accessories Applications CliniMACS CD34 Products were developed for the enrichment of CD34 cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System Referenced literature CD34 enrichment of progenitor cells is performed to provide an allogeneic stem cell graft highly purified for CD34 cells and depleted of unwanted cells In autologous transplantation CD34 progenitor cells can be enriched in order to passively remove tumor cells from the graft 12 13 purging References Elmaagacli et al 2003 Blood 101 2 446 453 Bornhaeuser et al 2000 Haematologica 85 839 847 Lang etal 2003 Blood 101 1630 1636 Aversa et al 2002 Int J Hematol 76 Suppl 1 165 168 Chakraverty et al 2002 Blood 99 3 1071 1078 Craddock et al 2000 Br J Haematol 111 3 797 800 Gaipa et al 2003 Bone Marrow Transplant 31
75. proliferative activity The high potential for hematopoietic engraftment of isolated CD133 cells has been shown in NOD SCID repopulation assays CD133 enriched cells have also been used as a starting fraction for the ex vivo expansion of hematopoietic progenitor cells from cord blood Clinically CD133 enriched stem cell grafts have been employed in autologous and allogeneic transplantation not only in the haploidentical but also in the HLA matched setting Additionally CD133 stem cells can be utilized in non hematological applications such as regenerative medicine CD133 is expressed on stem progenitor cells of different tissues including bone marrow peripheral blood cord blood and liver CD133 stem cells have been shown to harbor the capability to differentiate in vitro into cell types of various tissues Bone marrow derived CD133 stem cells have come into focus in non hematological applications especially ischemic heart diseases Clinical trials are currently being conducted to address safety and feasibility of this approach Performance Since its introduction the CliniMACS CD133 System has demonstrated excellent performance providing CD133 progenitor cells with high purity and yield in conjunction with excellent passive depletion of unwanted cells see table 1 References 1 De Wynter et al 1998 Stem Cells 16 387 396 2 Goussetis et al 2000 J Hematother amp Stem Cell Re
76. r magnetic labeling of up to 4x10 CD8 cells from up to 40x10 total cells Please inquire about recommended device and accessories Applications CliniMACS CD8 Products were developed for depletion of CD8 T cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System Referenced literature In the allogeneic transplantation setting CD8 T cells may be removed from a graft or DLI with the goal of preventing GVHD while maintaining GVL effects Additionally the depletion of CD8 T cells might be part of a strategy for the enrichment of regulatory T cells Enrichment of CD8 T cells is also an option for the generation of specific T cell lines References Nimeret ol 1994 Transpl 57 82 87 Baron et al 2003 Haematologica 88 835 837 1 2 3 Meyer etal 2004 Blood 104 5069 4 5 Meyer etal 2007 Blood 109 374 382 Savoldo et al 2002 Blood 100 4059 4066 www miltenyibiotec com A Before depletion B After depletion CD4 14 15 19 PE CD4 14 15 19 PE CD8 FITC CD8 FITC Figure 1 Flow cytometric analysis of CD8 depleted cells using the CliniMACS CD8 System Ld Related MACS Products CD8 FITC human 130 080 601 CD8 PE human 130 091 084 CD8 APC human 130 091 076 CD4 PE human 130 091 231 CD4 APC human 130 091 232 CD3 FITC human 130 080 401 CD25 Biotin human 130 091 235 Anti Biotin
77. ralia Pty Ltd Unit 16A 2 Eden Park Drive North Ryde NSW 2113 Australia Phone 61 02 8877 7400 Fax 61 02 9889 5044 macs miltenyibiotec com au Benelux Miltenyi Biotec B V Postbus 85183 3508 AD Utrecht The Netherlands macs miltenyibiotec nl Customer service Netherlands Phone 0800 4020120 Fax 0800 4020100 Customer service Belgium Phone 0800 94016 Fax 0800 99626 Customer service Luxembourg Phone 800 24971 Fax 800 24984 China Miltenyi Biotec Trading Shanghai Co Ltd Shanghai Office Fareast International Plaza A Rm 2301 No 319 Xianxia Rd Shanghai 200051 P R China Phone 86 21 62351005 Fax 86 21 62350953 macs miltenyibiotec com cn France Miltenyi Biotec SAS 10 rue Mercoeur 75011 Paris France Phone 33 1 56 98 16 16 Fax 33 15698 16 17 macs miltenyibiotec fr Italy Miltenyi Biotec S r l Via Persicetana 2 D 40012 Calderara di Reno BO Italy Me Phone 39 051 6 460 411 Fax 39 051 6 460 499 macs miltenyibiotec it Japan Miltenyi Biotec K K Nittsu Eitai Building 5F 16 10 Fuyuki Koto ku Tokyo 135 0041 Japan Phone 81 3 5646 8910 Fax 81 3 5646 8911 macs miltenyibiotec jp Singapore Miltenyi Biotec Asia Pacific Pte Ltd 100 Beach Road 28 06 to 28 08 Shaw Tower Singapore 189702 Phone 65 6238 8183 Fax 65 6238 0302 macs miltenyibiotec com sg Spain Miltenyi Biotec S L C Luis Bu uel 2 Ciudad de la Imagen 28223 Pozuelo de Alarc n Madrid
78. ription The CliniMACS PBS EDTA Buffer consists of phosphate buffered saline pH 7 2 supplemented with 1 mM EDTA The buffer is supplied in 1 L plastic bags as a sterile non pyrogenic solution www miltenyibiotec com Application CliniMACS PBS EDTA Buffer was developed for cell preparation and separation of magnetically labeled cells with the CliniMACS System Figure 1 CliniMACS PBS EDTA Buffer for research use 36 D 4 N as vA e FN i on D NN OU bg Un UJ et U D N Z N a e i Q D TS D J Un U lt U Accessories Cell culture products The technical features of Miltenyi Biotec cell culture bags make them valuable tools for investigators interesting in culturing cells The bags are gas permeable transparent for microscopy and allow for a closed culture system resulting in reduced risk of contamination The bags are individually packed sterile and tested for endotoxins They come in single tube format or with six needleless access connectors fitting standard laboratory requirement The single tube can be used for sterile docking according to the instructions for use of the tube welding device Transfer devices with a male luer lock connector e g tubing or syringe can be attached directly to the needleless access connectors Cell Differentiation Bags are available for three different culture volumes 100 mL
79. rug IND application or Investigational Device Exemption IDE Description The CliniMACS PBS EDTA Buffer consists of phosphate buffered saline pH 7 2 supplemented with 1mM EDTA The buffer is supplied in 1L plastic bags as a sterile non pyrogenic solution Application CliniMACS PBS EDTA Buffer was developed for cell preparation and separation of magnetically labeled cells with the CliniMACS System CliniMACS PBS EDTA Buffer is not intended for direct infusion into humans The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans CliniMACS PBS EDTA Buffer for Research Use Product CliniMACS PBS EDTA Buffer for Research Use Content 3x1L plastic bags Regulatory status For research use only not for use in humans Figure 1 CliniMACS PBS EDTA Buffer Availability Order no US 705 25 For availability in your country please contact your local representative 1 Manufactured under an ISO 9001 certified quality system Desc
80. s 9 827 840 3 Kuci et al 2003 Blood 101 869 876 4 Handgretinger et al 2003 Ann N Y Acad Sci 996 141 151 5 Pasino et al 2000 Brit J Haematol 108 793 800 6 Forraz et al 2002 Brit J Haematol 119 516 524 7 Kobariet al 2001 J Hematother amp Stem Cell Res 10 273 281 8 Peled et al 2004 Cytother 6 344 355 9 Kohl etal 2002 Bone Marrow Transpl 29 927 930 10 Falzetti et al 2002 Blood 100 11 831a 11 Lang et al 2004 Brit J Haematol 124 72 79 12 Lang et al 2004 Bone Marrow Transpl 33 879 880 13 Bornhaeuser et al 2005 Leukemia 19 161 165 14 Pompilio et al 2004 Ann Thorac Surg 78 5 1808 1812 15 Klein et al 2004 The Heart Surgery Forum Vol 7 Issue 5 16 Ghodsizad et al 2004 Cytotherapy 6 5 523 526 17 Stamm et al 2004 Thorac Cardiovasc Surg 52 3 152 158 18 Stamm et al 2003 Lancet 361 9351 45 46 19 Gordon et al 2003 Bone Marrow Transpl 31 17 22 20 Lang et al 2004 ISCT Dublin Miltenyi Biotec Satellite Symposium 21 Bornhaeuser et al 2005 Leukemia 19 161 165 O Pluripotent Stem Cell CD133 CD34 O Hematopoietic Stem Cell CD133 CD34 C D N Z UY a e i Cx D TA D Un d lt U Q CFU GEMM CD133 CD34 Q Q BFU E CD133 CD34 CFU GM CD133 CD34 O Q CFU E CFU Meg CFU Eo CD34 CD133 CD34
81. s Availability Order no Transfer Bag 150 mL 5 Bags CE Europe 183 01 Transfer Bag 600 mL 5 Bags CE Europe 190 01 Transfer Bag 1000 mL 5 Bags CE Europe 180 01 For availability in your country please contact your local representative Description Please inquire about recommended device Transfer Bag 150 mL and accessories Suitable for collecting the positive fraction during a CliniMACS Separation in combination with a Luer Spike Interconnector Sterilized non pyrogenic single packed Transfer Bag 600 mL Suitable for cell labeling procedures Sterilized non pyrogenic single packed Figure 1 The Transfer Bag 150 mL Transfer Bag 1000 mL Suitable for collecting fractions during a CliniMACS Separation in combination with a Luer Spike Interconnector Sterilized non pyrogenic single packed Transfer Bag 600 mL with 8 couplers Product Content Regulatory status Availability Order no Transfer Bag 600 mL 5 Bags CE Europe 184 01 with 8 couplers For availability in your country please contact your local representative Description Please inquire about recommended device The Transfer Bag with eight couplers and accessories Octopus Bag is suitable for cell labeling procedures This Transfer Bag enables the operator to perform the sample preparation procedure in a closed system Sterilized non pyrogenic single packed Figure 1 The Transfer Bag 600 mL with 8 couplers Octopus bag
82. s of the software The upgrade is CE compliant Existing basic CliniMACS Instruments can be upgraded The CliniMACS System components Reagents Tubing Sets Instruments and PBS EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Kit components CliniMACS Plus Upgrade Kit Software 755 16 e Software Card e CliniMACS User Manual e 2 Bag Hanger assemblies CliniMACS MicroBeads are for research use only and not for use in humans e Stabilization foot ww w miltenyibiotec com Service contracts CliniMACS Service Contracts Product CliniMACS Full Service Agreement Availability Europe Order no 160 000 973 CliniMACS Maintenance Europe 160 000 974 CliniMACS Premium Service Agreement CAN US 160 000 701 CliniMACS Basic Service Agreement CAN US 160 000 702 For availability in your country please contact your local representative www miltenyibiotec com D 4 N z vA e i on D N OU J Un UJ lt x U CliniMACS Tubing Sets CliniMACS Tubing Set and Tubing Set LS Product Components Regulatory
83. se in humans Unless otherwise specifically indicated Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use CliniMACS T and B cell depletion CD3 CD19 combination Using the CliniMACS System together Safety and feasibility of CD3 CD19 However with the CliniMACS Tubing with the CliniMACS CD3 CD19 Combination depleted grafts in the haploidentical Set LS the depletion procedure is makes it possible to simultaneously and unrelated donor setting have been limited to a maximum of 20 x10 deplete T cells and B cells from a graft explored in a number of clinical studies labeled cells Therefore a new tubing set was developed called the In contrast to stem cell enrichment Table 1 summarizes the CD3 CD19 CliniMACS Depletion Tubing Set which this method preserves NK cells and depletion results with the CliniMACS has been designed for depletion of up other effector cells in the graft see also System and the CliniMACS Tubing Set LS to 40 x10 labeled cells with a reduced table 1 processing time The new procedure uses the program DEPLETION 3 1 software version 2 40 or higher pss 0 325 n 6 n 14 Cell source PBSCs PBSCs PBSCs BM References F 1 Barfield et al 2004 Cytother 6 1 6 Recovery CD34 63 ay Zi SH 2 Benaim et al 2003 Blood 102 11 969a Recovery NK cells 96 36 nd 67 75 3 Lang et al 2004 ISCT Dublin Remaining T cells 96 0 02 0 01 nd 0 11 Miltenyi Biotec Sate
84. specifically help CD8 T cells during an immune reaction but also seem to support their prolonged survival in the recipient The depletion of CD8 T cells from DLI is described in various protocols for the prevention of GVHD The CliniMACS CD4 Reagent and CD8 Reagent are the reagents of choice for investigating potential applications based on such rationale CD25 was first described asa T cell proliferation marker It is now regarded as a marker which defines activated reactive T cells MHC class Il presentation Antibody production B cell CH Different cytokines Alloreactive T cells can cause severe complications GVHD in transplantation Thus it may be desirable to deplete CD25 T cells from apheresis products CD25 CD4 regulatory T cells are the focus of T cell research as they have been shown to be capable of specifically modulating immune reactions For a variety of applications these modulating capacities could potentially be utilized The CD25 T cells can be depleted or enriched using the CliniMACS CD25 System Antigen specific T cells have become another focus in T cell research and opportunities for utilizing such cells for clinical scale applications are being exploited In order for an antigen specific CD8 cell to survive long enough and thus be able to fight an infection or a tumor the help of CD4 T cells is mandatory The CliniMACS Cytokine Capture System IFN gamma is the first product de
85. tin 277 01 Biotinylated primary antibody CliniMACS MicroBeads are for research use only and not for use in gl Related MACS Products humans Anti Biotin FITC 130 090 857 Fi E usina CIIniMACS eo we E igure 2 Labeling principle using Clint Unless otherwise specifically indicated Miltenyi Biotec products and SU EN PE 130 090 756 Anti Biotin Products services are for research only and not for therapeutic or diagnostic use Anti Biotin APC 130 090 856 CliniMACS Biotinylation Kit 500 Product Regulatory status Capacity Availability Order no CliniMACS Biotinylation Kit 500 CE Biotinylation of 500 ug Europe US NEW 701 06 monoclonal antibody CliniMACS Biotinylation Kit 500 For research use only Biotinylation of 500 ug US CAN AUS 257 01 for Research Use not for use in humans monoclonal antibody For availability in your country please contact your local representative 1 Outside Europe the CliniMACS Biotinylation Kit 500 is for research use only 2 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Description Applications The CliniMACS System components Reagents Tubing Sets Instruments and The CliniMACS Biotinylation Kit 500 One kit is sufficient for biotinylating PBS EDTA Buffer are manufactured and controlled under an ISO 13485
86. tire process of cell enrichment is performed in a closed sterile system The resulting viable cells may be directly used in subsequent steps of the respective protocol Alternatively the cells may be manipulated or expanded in vitro or phenotypically analyzed References 1 Cohen et al 2002 Virology 304 474 2 Bissinger et al 2002 Exp Hematol 30 1178 3 Dudley et al 2002 Science 298 850 4 Campbell 2003 Methods 31 150 159 5 Feuchtinger et al 2004 Exp Hematol 32 282 289 6 Rauser et al 2004 Blood 103 3565 3572 24 C D 4 N z U e is SS D NN D LO Un d et U D 4 N Z Y a e i ge Q D TA OU Un UJ lt x U Antigen specific T cells IFN y secreting antigen specific T cells Product CliniMACS Cytokine Capture System IFN gamma Regulatory status Capacity max CE 1x10 total cells Availability Order no Europe US 279 01 CliniMACS Cytokine Capture System IFN gamma MicroBeads For research use only 1X10 total cells not for use in humans US CAN AUS 287 01 For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Description Interferon g
87. tly from blood no long culturing period as for MoDC generation is needed Figure 1 Mature blood dendritic cell stained with HLA DR FITC References Dietz et al 2004 Cytotherapy 6 6 563 570 Curti et al 2004 Leukemia amp Lymphoma 45 7 1419 1428 Meyer Wentrup et al 2003 J Hematother amp Stem Cell Res 12 289 299 Sorg et al 2003 J Immunol 26 4 374 383 Motta et al 2003 Br J Haematol 121 240 250 Prasadetal 2005 J Immunol 174 90 98 Schnurr et al 2005 Blood 105 2465 2472 Dzionek etal 2002 Hum Immunol 63 1133 1148 ww w miltenyibiotec com Dendritic cells CliniMACS CD14 Cell Enrichment Product CliniMACS CD14 Reagent CE Regulatory status Capacity max 4x10 CD14 cells Availability Order no Europe US 272 01 from 20 x 10 total cells CliniMACS CD14 Complete Kit CE marked components 4x10 CD14 cells Europe 281 01 from 20 x10 total cells CliniMACS CD14 MicroBeads For research use only not for use in humans 4x10 CD14 cells from 20 x 10 total cells US CAN AUS 191 01 For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE Description The CD14 antigen belongs t
88. truments and PBS EDTA Buffer are manufactured and controlled under an cells from human heterogeneous ISO 13485 certified quality system In Europe the CliniMACS System hematologic cell populations in components are available as CE marked medical devices In the USA the combination with the CliniMACS System CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE References 1 Dzionek et al 2000 J of Immunology 165 6037 6046 898 CliniMACS MicroBeads are for research use only and not for use in 2 Dzionek et al 2002 Hum Immunol 63 12 1133 1148 2423 humans Unless otherwise specifically indicated Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use D 4 N z vA e i on D N OU ied Un UJ lt x U www miltenyibiotec com 34 Flexible labeling system CliniMACS Anti Biotin Product Regulatory status Capacity Availability Order no CliniMACS Anti Biotin Reagent CE 40x10 Europe US 173 01 total cells CliniMACS Anti Biotin MicroBeads For research use only 40 x10 US CAN AUS 192 01 not for use in humans total cells For availability in your country please contact your local representative 1 In the USA the CliniMACS System components including the CliniMACS Reagents are availabl
89. un Street Amman Jordan 100 Shevchenko str 08300 Boryspil Almac House Church Lane Bisley Surrey GU24 9DR UK 12740 Earhart Avenue Auburn CA 95602 USA Urbanizacion Terrazas del Club Hipico Complejo Residencial Brisas del Prado Terraza A Centro Comercial Brisas del Prado Local Comercial No 7 Caracas Edo Miranda Friedrich Ebert Strale 68 51429 Bergisch Gladbach Germany Phone 82 2 424 6367 Fax 82 2 412 6535 Phone 34 91 512 1290 Fax 3491 512 1291 Phone 49 2204 8306 0 Fax 49 2204 85197 Phone 65 6238 8183 Fax 65 6238 0302 Phone 66 2 9356 761 Fax 66 2 9356 766 Phone 90 216 360 62 74 Fax 90 216 360 62 75 Phone 962 6 4655166 Fax 962 6 4655167 Phone 38 044 503 60 25 Fax 38 044 503 60 29 Phone 44 1483 799 800 Fax 44 1483 799 811 Phone 1 530 888 8871 Fax 1530 745 2899 Phone 58 212 975 2617 Fax 58 212 978 4180 Phone 49 2204 8306 0 Fax 49 2204 85197 In the United States CliniMACS products for clinical use are available only under an approved Investigational Device Exemption IDE clinimacs medilab co kr www medilabkorea com macs miltenyibiotec es www miltenyibiotec com macs miltenyibiotec de www miltenyibiotec com clinimacs miltenyibiotec com sg www miltenyibiotec com interco blood co th mak makmedikal com www makmedikal com modhafar alyamamagroup com www alyamamagroup com d tatarkin maxwell pharma com www maxwell pharma com macs milteny
90. urope US US CAN AUS Europe US US CAN AUS Europe US US CAN AUS Europe US US CAN AUS Order no NEW 171 01 178 01 177 01 170 01 169 01 175 01 172 01 196 01 198 01 197 01 199 01 195 01 704 00 740 01 740 02 273 01 176 01 276 01 304 01 275 01 308 01 274 01 325 01 279 01 287 01 In Europe the CliniMACS System components are available as CE marked medical devices In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE CliniMACS MicroBeads are for research use only and not for use in humans 2 In the USA the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug IND application or Investigational Device Exemption IDE www miltenyibiotec com D 4 Un Z N K e Fe m D N OU Un UI lt z U D J Un Z N C e 4 z t D NN D WJ Un UJ lt x 2 i U Product overview Page 28 28 28 28 30 30 32 32 32 33 33 33 34 35 35 35 35 36 36 Product NK cells CliniMACS CD56 Reagent CliniMACS CD3 CD56 Reagent Combination CliniMACS CD3 CD56 Complete Kit CliniMACS CD56 MicroBeads B cells CliniMACS CD19 Reagent CliniMACS CD19 MicroBeads Dendriti
91. use Malaysia Mexico Netherlands New Zealand Northern Ireland Oman Pakistan Peru Poland Portugal Qatar Romania Russia Saudi Arabia Singapore Slovak Republic South Africa 45 T Medic Sdn Bhd UNIPARTS S A DE C V Miltenyi Biotec B V Miltenyi Biotec Australia Pty Ltd Ulster Anaesthetics Ltd Al Yamama T amp A Scientific Inmunochem MEDianus Sp z o o Citomed Lda Al Yamama NOVAINTERMED POCARD Ltd Global Health Company Miltenyi Biotec Asia Pacific Pte Ltd BIOHEM spol s r o BIOCOM Biotech H 0 11 Jalan Sri Hartamas 1 1 70A 60 Plaza Damas Sri Hartamas Taman Sri Hartamas 50480 Kuala Lumpur Malaysia Galileo 92 Colonia Polanco 11550 Mexico D F Mexico Postbus 85183 3508 AD Utrecht The Netherlands Unit 16 A 2 Eden Park Drive North Ryde NSW 2113 Australia Maryland Industrial Estate 286 Ballygowan Road Moneyrea BT23 6BL Northern Ireland Al Saif Medical Centre Ibn Khaldoun Street Amman Jordan 5 206 C 3rd Floor Shahida Mension Central Commercial Area P E C H S Block 2 Karachi 75400 Pakistan Luis F Villaran 904 27 Lima Peru Ul Cysters w 13 2 31 553 Krak w Poland Rua D Luis de Noronha no 4 7 piso 1050 072 Lisboa Portugal Al Saif Medical Centre Ibn Khaldoun Street Amman Jordan No 5A Drumul Potcoavei str 077190 Pipera Tunari Ilfov Romania 3 rd Cherepkovskay 15a 121552 Moscow Russia
92. ved Investigational Device Exemption IDE direccion lab systems com ar www lab systems com ar macs miltenyibiotec com au www miltenyibiotec com macs miltenyibiotec de www miltenyibiotec com modhafar alyamamagroup com www alyamamagroup com bioscience open by macs miltenyibiotec nl www miltenyibiotec com biol ambriex com br www ambriex com br info eemed gr www eemed gr macs miltenyibiotec com www miltenyibiotec com ursulab entelchile net www ub co cl macs miltenyibiotec com cn www miltenyibiotec com macs miltenyibiotec com cn www miltenyibiotec com equimedcomercial etb net co damir jambrosicemediva hr www mediva hr info eemed gr www eemed gr biohem biohem sk www biohem sk frisonex frisonex com modhafar alyamamagroup com www alyamamagroup com www miltenyibiotec com Distributors products for clinical use Estonia France Germany Greece Hong Kong Hungary India Indonesia Israel Italy Japan Jordan Kuwait Latvia Lebanon Lithuania Luxembourg AS Oriola Miltenyi Biotec SAS Miltenyi Biotec GmbH Epsilon amp Epsilon Medical S A Miltenyi Biotec Trading Shanghai Co Ltd Shanghai Office Frank Diagnosztika Kft Medicons PT TRANSMEDIC INDONESIA Y A Almog Diagnostic amp Medical Equipment Ltd Miltenyi Biotec S r l Miltenyi Biotec K K Al Yamama TRI ALPHA CO Oriola Riga SIA Al Yamama UAB Oriola
93. veloped that allows the concomitant clinical scale enrichment of both CDA and CD8 T cells specific for a given antigen References Barfield et al 2004 Cytotherapy 6 1 6 lyengar et al 2003 Cytotherapy 5 6 479 484 Falkenburg et al 1999 Blood 94 4 1201 1208 Rosenberg et al 2004 PNAS USA 101 14639 14645 Soiffer et al 2002 Biol Blood Marrow Transplant 8 625 632 Andr Schmutz et al 2002 Lancet 360 130 137 Hoffmann et al 2004 Blood 104 895 903 Hoffmann et al 2004 Blood 104 2851 Powell et al 2005 J Immunother 28 403 411 10 Feuchtinger et al 2004 Exp Hem 32 282 289 so C2 5 p Ew pg Swe e CH o CDA effector cell 810461255 Ag specific cell TGF B IL 10 CD8 CD25 Q activated IFN y Perforins allo reactive CD4 CD25 regulatory cell arises from Granzymes cell Ag specific CD4 pool I CD8 e CD25 A CD4 a TCR MHC class II MHC class Figure 1 Schematic diagram of the interface between dendritic cells and T cells C D N Z UY a e Cx D T D J Un d lt U 1 9 www miltenyibiotec com T cells CliniMACS CD3 Cell Depletion Product Regulatory status Capacity max Availability Order no CliniMACS CD3 Reagent CE 15 x10 CD3 cells Europe US 273 01 from 40 x10 total cell CliniMACS CD3 MicroBeads For research use only 15 x10 CD3 cells US CAN AUS 176 01 not for use in humans fro
94. ww medianus net info citomed pt www citomed pt modhafar alyamamagroup com www alyamamagroup com customer_care_rep2 novaintermed ro www hovaintermed ro pocard cardio ru www pocard ru feky1 gawab com clinimacs miltenyibiotec com sg www miltenyibiotec com biohem biohem sk www biohem sk info biocombiotech co za www biocombiotech co za www miltenyibiotec com Distributors products for clinical use South Korea Spain Switzerland Taiwan Thailand Turkey United Arab Emirates Ukraine United Kingdom United States Venezuela Other countries Medilab Korea Co Ltd Miltenyi Biotec S L Miltenyi Biotec GmbH Miltenyi Biotec Asia Pacific Pte Ltd Venus Technology Co Ltd MAK Sa l k r nleri Ith hr Tic San Itd Sti Al Yamama MAX WELL SOCPS Miltenyi Biotec Ltd Miltenyi Biotec Inc Biologia Molecular y Biotecnologia Miltenyi Biotec GmbH www miltenyibiotec com 4 F WonHyun Building 190 15 Bangyi Dong Songpa Gu Seoul 138 050 Korea C Luis Bu uel 2 Ciudad de la Imagen 28223 Pozuelo de Alarc n Madrid Spain Friedrich Ebert Stra e 68 51429 Bergisch Gladbach Germany 100 Beach Road 28 06 to 28 08 Shaw Tower Singapore 189702 636 2 Soi Ramkhamhaeng 39 Theplila 1 Prachautit Road Wangthonglang Bangkok 10310 Thailand Cevizlidere Mah Ceyhun Atuf Kansu cad No 137 12 6450 Balgat Ankara Turkey Al Saif Medical Centre Ibn Khaldo

CliniMACS® Cell Separation System, Product catalog 2008

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CliniMACS&reg; Cell Separation System, Product catalog 2008

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CliniMACS® Cell Separation System, Product catalog 2008