CliniMACS Prodigy® Instrument

Selected references 

1. Lock, D. et al. (2017) Automated manufacturing of potent CD20-directed chimeric antigen receptor T cells for clinical use. Hum. Gene Ther. 28(10): 914-925 
2. Klöß, S et al. (2017) Optimization of human NK cell manufacturing: Fully automated separation, improved ex vivo expansion using IL-21 with autologous feeder cells, and generation of Anti-CD123-CAR-expressing effector cells. Hum. Gene Ther. 28(10): 897-913 
3. Editorial (2017) The key to unlocking CARs. Nat. Biotechnol. 35(10): 889 
4. Tarnowski, J. et al. (2017) Delivering advanced therapies: the big pharma approach. Gene Ther. 24(9): 593-598 
5. Fraser, A. R. et al. (2017) Development, functional characterization and validation of methodology for GMP-compliant manufacture of phagocytic macrophages: A novel cellular therapeutic for liver cirrhosis. Cytotherapy 19(9): 1113-1124 
6. Pello, O. M. et al. (2017) BKV-specific T cells in the treatment of severe refractory haemorrhagic cystitis after HLA-haploidentical haematopoietic cell transplantation. Eur. J. Haematol. 98(6): 632-634 
7. Skorska, A. et al. (2017) GMP-conformant on-site manufacturing of a CD133(+) stem cell product for cardiovascular regeneration. Stem Cell Res. Ther. 8(1): 33 
8. Levine, B. L. et al. (2016) Global manufacturing of CAR T cell therapy. Mol. Ther. Methods Clin. Dev. 4: 92-101 
9. Priesner, C. et al. (2016) Automated enrichment, transduction and expansion of clinical-scale CD62L+ T cells for manufacturing of GTMPs. Hum. Gene Ther. 27(10): 860-869 
10. Priesner, C. et al. (2016) Comparative analysis of clinical-scale IFN-γ-positive T cell enrichment using partially and fully integrated platforms. Front Immunol 7: 393 
11. Mock, U. et al. (2016) Automated manufacturing of chimeric antigen receptor T cells for adoptive immunotherapy using CliniMACS prodigy. Cytotherapy 18(8): 1002-1011 
12. Takashi, I. et al. (2016) Multiple allogeneic progenitors in combination function as a unit to support early transient hematopoiesis in transplantation. J. Exp. Med. 213(9): 1865-1880 
13. Wang, X. and Rivière, I. (2016) Clinical manufacturing of CAR T cells: foundation of a promising therapy. Mol. Ther. Oncolytics 3: 16015 
14. Walker, A. and Johnson, R. (2016) Commercialization of cellular immunotherapies for cancer. Biochem. Soc. Trans. 44(2): 329-332 
15. Hümmer, C. et al. (2016) Automation of cellular therapy product manufacturing: results of a split validation comparing CD34 selection of peripheral blood stem cell apheresis product with a semi-manual vs. an automatic procedure. J. Transl. Med. 14: 76 
16. Stroncek, D. F. et al. (2016) Preliminary evaluation of a highly automated instrument for the selection of CD34+ cells from mobilized peripheral blood stem cell concentrates. Transfusion 56(2): 511-517 
17. Bunos, M. et al. (2015) Automated isolation of primary antigen-specific T cells from donor lymphocyte concentrates: results of a feasibility exercise. Vox sang. 109(4): 387-393 
18. Spohn, G. et al. (2015) Automated CD34+ cell isolation of peripheral blood stem cell apheresis product. Cytotherapy 17(10): 1465-1471 
19. Kumaresan, P. et al. (2015) Automated cell enrichment of cytomegalovirus-specific T cells for clinical applications using the cytokine-capture system. J. Vis. Exp. 104: e52808 
20. Sorg, N. et al. (2015) Red blood cell depletion from bone marrow and peripheral blood buffy coat: a comparison of two new and three established technologies. Transfusion 55(6): 1275-1282 
21. Granzin, M. et al. (2015) Fully automated expansion and activation of clinical-grade natural killer cells for adoptive immunotherapy. Cytotherapy 17(5): 631-632 
22. Apel, M. et al. (2013) Integrated clinical scale manufacturing system for cellular products derived by magnetic cell separation, centrifugation and cell culture. Chemie Ingenieur Technik 85: 103-110

Selected references 

• CliniMACS Prodigy® - selected references

Brochures and posters 

• CliniMACS Prodigy System 
• CliniMACS Prodigy T Cell Transduction 
• CliniMACS Prodigy ACC Application Sheet pluripotent stem cell expansion 
• CAR T cells 
• CliniMACS Prodigy ACC Application Sheet - mesenchymal stem cell expansion 
• CliniMACS Prodigy ACC Application Sheet - PSC to mesencephalic dopaminergic progenitor differentiation 
• CliniMACS Prodigy TCT Transduction Application Sheet
• CliniMACS Prodigy HSC Engineering Application Sheet

Scientific posters 

• Automation of hematopoietic stem cell transduction: Results of a head-to-head comparison between a manual and an automated procedure. Bissels, U. et al. (2019) ESGCT
• Efficient GMP-compliant expansion of mesenchymal stromalcells (MSCs) from umbilical cord, bone marrow, and adiposetissue using a closed cultivation system. Godthardt, K. - ISCT 2019
• GMP-compliant expansion of mesenchymal stromal cells (MSCs) using the CliniMACS Prodigy® and xeno-free MSC-Brew GMP Medium
• Fully integrated closed-system expansion and differentiation of pluripotent stem cells towards mesencephalic dopaminergic progenitor cells. 
• Scalable process for standardized generation of human PSC-derived cardiomyocytes. 
• Standardized QC assays and (automated) expansion of pluripotent stem cells 
• Safety assessment of MACS® GMP T Cell TransAct 
• Automated manufacturing of gene-engineered T cells under serum-free conditions 
• Automated clinical-scale retroviral transduction of T cells in a functionally closed system 
• Polyclonal T cell activation and expansion tool for clinical-scale manufacturing - ICIC 2017 
• Effective retroviral transduction of primary T cells and hematopoieticstem cells using the soluble transduction enhancer: Vectofusin-1®

Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research use only and not for therapeutic or diagnostic use. MACS® GMP Products are for research use and ex vivo cell culture processing only, and are not intended for human in vivo applications. For regulatory status in the USA, please contact your local representative. MACS GMP Products are manufactured and tested under a quality system certified to ISO 13485 and are in compliance with relevant GMP guidelines. They are designed following the recommendations of USP <1043> on ancillary materials. The CliniMACS® System components, including Reagents, Tubing Sets, Instruments, and PBS/EDTA Buffer, are designed, manufactured and tested under a quality system certified to ISO 13485. 

In the EU, the CliniMACS System components are available as CE-marked medical devices for their respective intended use, unless otherwise stated. The CliniMACS Reagents and Biotin Conjugates are intended for in vitro use only and are not designated for therapeutic use or direct infusion into patients. The CliniMACS Reagents in combination with the CliniMACS System are intended to separate human cells. Miltenyi Biotec as the manufacturer of the CliniMACS System does not give any recommendations regarding the use of separated cells for therapeutic purposes and does not make any claims regarding a clinical benefit. For the manufacturing and use of target cells in humans the national legislation and regulations – e.g. for the EU the Directive 2004/23/EC (“human tissues and cells”), or the Directive 2002/98/EC (“human blood and blood components”) – must be followed. Thus, any clinical application of the target cells is exclusively within the responsibility of the user of a CliniMACS System. 

In the US, the CliniMACS CD34 Reagent System, including the CliniMACS Plus Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing Sets TS and LS, and the CliniMACS PBS/EDTA Buffer, is FDA approved; all other products of the CliniMACS Product Line 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 human therapeutic or diagnostic use.  

In the US, the CliniMACS Prodigy® T Cell Transduction Process is available for research use only.  
CliniMACS, CliniMACS Prodigy, MACS, and the MACS logo are registered trademarks or trademarks of Miltenyi Biotec B.V. & Co. KG and/or its affiliates in various countries worldwide. Copyright © 2019 Miltenyi Biotec B.V. & Co. KG and/or its affiliates. All rights reserved.