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Point-of-care cell therapy manufacturing; it's not for everyone
David F Stroncek1, Robert P T Somerville2, Steven L Highfill2
1Center for Cellular Engineering, Department of Transfusion Medicine, NIH Clinical Center, 10 Center Drive-MSC-1184, Building 10, Room 1C711, Bethesda, MD, 20892-1184, USA. dstroncek@cc.nih.gov.
Journal of Translational Medicine
|January 16, 2022
Summary
Decentralized cellular therapy manufacturing offers potential but presents significant challenges. Harmonizing protocols and quality programs across multiple sites is crucial for successful clinical trials, and may not be cost-effective for all academic centers.
Area of Science:
- Biotechnology
- Oncology
- Immunology
Background:
- Cellular therapies are increasingly used for treating cancer, immune deficiencies, hemoglobinopathies, and viral infections.
- Automated instruments and reagents are being developed for cellular therapy production.
- A decentralized manufacturing model is proposed for multi-site clinical trials, using automated instruments at each center under a single Investigational New Drug Application (IND).
