Future-proofing cell therapy manufacturing capability: lessons from the NCI

Published: 20 April 2021
Commentary
Anthony Welch,
Anthony Welch
Biological Resources Branch, DTP/ DCTD/NCI
Marc Ernstoff,
Marc Ernstoff
ImmunoOncology Branch, DTP/ DCTD/NCI
Jason Yovandich
Jason Yovandich
Biological Resources Branch, DTP/ DCTD/NCI

The current state of cell therapy manufacturing includes centralized and decentralized models, autologous and off-the-shelf approaches, and various viral and gene editing methods for engineering the cell product. The National Cancer Institute’s (NCI’s) Division of Cancer Therapy and Diagnosis (DCTD) supports a cGMP pilot plant for manufacture of cell and gene therapy products including cGMP lentivirus and gamma-retrovirus vectors for use in cell therapy production. DCTD offers these resources and know-how to innovators through the NCI Experimental Therapeutics (NExT) Program and public workshops with the goal of optimizing and standardizing raw material selection, quality attribute testing, and product formulation.

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