GMP Compliant Production of a Cryopreserved Adipose-Derived Stromal Cell Product for Feasible and Allogeneic Clinical Use
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The emerging field of advanced therapy medicinal products (ATMP) holds promise of treating a variety of diseases. Adipose-derived stromal cells (ASCs) are currently being marketed or tested as cell-based therapies in numerous clinical trials. To ensure safety and efficacy of treatments, high-quality products must be manufactured. A good manufacturing practice (GMP) compliant and consistent manufacturing process including validated quality control methods is critical. Product design and formulation are equally important to ensure clinical feasibility. Here, we present a GMP-compliant, xeno-free, and semiautomated manufacturing process and quality controls, used for large-scale production of a cryopreserved off-the-shelf ASC product and tested in several phase I and II allogeneic clinical applications.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 4664917 |
| Tidsskrift | Stem Cells International |
| Vol/bind | 2022 |
| ISSN | 1687-966X |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
The authors owe special thanks to Brent Rice and Layka Abbasi, Terumo BCT, for technical expert assistance, and to COOK CGBT (SEXTON Biotechnologies) for development and supply of custom made hPL. Special thanks are due to Mojdeh Lotfi, Kirstine Joo Andreasen, Rebekka Harary S ndergaard, and Cecilie H eg Pedersen for technical assistance and Bjarke Follin and Morten Juhl for constructive discussions. We are grateful to Andreas Printzlau for performing procurement, to the donors for consenting to participate, and to the Blood Bank, Department of Immunology, Rigshospitalet University Hospital, Denmark, for supplying cryoprecipitate. This study was supported by the Innovation Fund Denmark (grant number 6153-00002B) and Horizon 2020 (grant number 643478).
Publisher Copyright:
© 2022 Mandana Haack-Sørensen et al.
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