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

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

Immuno-Oncology Insights 2021; 2(2), 51–55

10.18609/ioi.2021.015

Published: 20 April 2021
Commentary
Anthony Welch, Marc Ernstoff, Jason Yovandich

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.