Table 1.
| Author (year of publication) | Title | Device platform | Product/ Runs |
|---|---|---|---|
| a) Reviews | |||
| Fritsche E. et al. (73) | Toward an Optimized Process for Clinical Manufacturing of CAR-Treg Cell Therapy | 1. GMP compliant cell sorter 2. Bioreactor 3. CliniMACS Prodigy® |
|
| Mizukami A. and Swiech K. (72) | Platforms for Clinical-Grade CAR-T Cell Expansion Book: Chimeric Antigen Receptor T Cells (Chapter 10) |
1. Bioreactor 2. CliniMACS Prodigy® 3. Octane Cocoon™ cell culture system |
|
| Smith D. et al. (70) | Toward Automated Manufacturing for Cell Therapies | 1. Bioreactor 2. CliniMACS Prodigy® 3. Octane Cocoon™ cell culture system |
|
| Smith TA. (71) | CAR-T Cell Expansion in a Xuri Cell Expansion System W25 Book: Chimeric Antigen Receptor T Cells |
Xuri Cell Expansion System W25 | |
| Roddie C. et al. (69) | Manufacturing chimeric antigen receptor T cells: issues and challenges | 1. Wave Bioreactor 2. G-Rex flask 3. CliniMACS Prodigy® |
|
| Moutsatsou P. et al. (55) | Automation in cell and gene therapy manufacturing: from past to future | 1. CliniMACS Prodigy® 2. Octane Cocoon™ cell culture system 3. Quantum Cell Expansion (hollow fibers) |
|
| Iyer R.K. et al. (74) | Industrializing Autologous Adoptive Immunotherapies: Manufacturing Advances and challenges | 1. G-Rex static bioreactor 2. Wave-mixed Bioreactors 3. CliniMACS Prodigy® 4. Octane Cocoon™ cell culture system 5. Quantum Cell Expansion (hollow fibers) |
|
| Piscopo N.J. et al. (68) | Bioengineering Solutions for Manufacturing Challenges in CAR T Cells | 1. Bioreactors 2. CliniMACS Prodigy® |
|
| Kaiser A. et al. (67) | Toward a commercial process for the manufacture of genetically modified T cells for therapy | CliniMACS Prodigy® | |
| b) Paper | |||
| Costariol E. et al. (66) | Demonstrating the Manufacture of Human CAR-T Cells in an Automated Stirred-Tank Bioreactor | Stirred tank bioreactor | CD19 CAR-T Donors (n =3) |
| Jackson Z. et al. (56) | Automated Manufacture of Autologous CD19 CAR-T Cells for Treatment of Non-Hodgkin Lymphoma | CliniMACS Prodigy® | CD19 CAR-T trial participants (n = 31) |
| Castella M. et al. (65) | Point-Of-Care CAR T-Cell Production (ARI-0001) Using a Closed Semi-automatic Bioreactor: Experience From an Academic Phase I Clinical Trial | CliniMACS Prodigy® | CD19 CAR-T trial participants (n = 28) |
| Fernández L. et al. (64) | GMP-Compliant Manufacturing of NKG2D CAR Memory T Cells Using CliniMACS Prodigy | CliniMACS Prodigy® | NKG2D CAR Memory T Cells validation runs (n = 4) |
| Vedvyas Y. et al. (63) Erratum in (2020) | Manufacturing and preclinical validation of CAR T cells targeting ICAM-1 for advanced thyroid cancer therapy | CliniMACS Prodigy® | ICAM-1 CAR-T preclinical validation (n = 7) |
| Aleksandrova K. et al. (53) | Functionality and Cell Senescence of CD4/CD8-Selected CD20 CAR T Cells Manufactured Using the Automated CliniMACS Prodigy® Platform | CliniMACS Prodigy® | CD20 CAR-T establishing runs (n = 6) |
| Zhang W. et al. (62) | Characterization of clinical grade CD19 chimeric antigen receptor T cells produced using automated CliniMACS Prodigy system | CliniMACS Prodigy® | CD19 CAR-T establishing run (n = 1) |
| Blaeschke F. et al. (52) | Induction of a central memory and stem cell memory phenotype in functionally active CD4(+) and CD8(+) CAR T cells produced in an automated good manufacturing practice system for the treatment of CD19(+) acute lymphoblastic leukemia | CliniMACS Prodigy® | CD19 CAR-T autologous patients (n = 4) |
| Zhu F. et al. (61) | Closed-system manufacturing of CD19 and dual-targeted CD20/19 chimeric antigen receptor T cells using the CliniMACS Prodigy device at an academic Medical Center | CliniMACS Prodigy® | CD19 und CD20/CD19 CAR-T test runs (n = 7) |
| Lock D. et al. (60) | Automated Manufacturing of Potent CD20-Directed Chimeric Antigen Receptor T Cells for Clinical Use | CliniMACS Prodigy® | CD20 CAR-T test runs (n = 15) |
| Priesner C. et al. (59) | Automated Enrichment, Transduction, and Expansion of Clinical-Scale CD62L(+) T Cells for Manufacturing of Gene Therapy Medicinal Products | CliniMACS Prodigy® | GFP- T proof of principle n = 3 (4) |
| Mock U. et al. (58) | Automated manufacturing of chimeric antigen receptor T cells for adoptive immunotherapy using CliniMACS prodigy | CliniMACS Prodigy® | CD19 CAR-T test runs (n = 7) |
| c) Clinical Trials | |||
| NCT04196413 | GD2.BB.z.iCasp9-CAR T Cells | CliniMACS Prodigy® | n = 54 |
| NCT03467256 | CD19 CAR-T | CliniMACS Prodigy® | n = 18 |
| NCT04049383 | CAR-20/19-T cells | CliniMACS Prodigy® | n = 24 |
| NCT03144583 | CD19 CAR-T | CliniMACS Prodigy® | n = 28 |
| NCT03434769 | CD19 CAR-T | CliniMACS Prodigy® | n = 31 |
| NCT03893019 | CD20 CAR-T | CliniMACS Prodigy® | n = 15 |
| Unknown | CD19 CAR-T | Cocoon® Platform | n = 1 |