Impact of contracted manufacturing organization protocols on operations in an aca demically based Current Good Manufacturing Practice facility.

ABSTRACT: Immunotherapy of cancer and other diseases is often dependent on adoptive transfer to patients of cellular products generated in Current Good Manufacturing Practice (cGMP) facilities. With the availability and approval of various cellular products for therapy, cell production facilities are experiencing unprecedented growth in demand for services. Increasingly, these services involve processing of externally generated cells for transfer to the bedside. The arrival of cells from external manufacturing facilities for processing and eventual infusion of cell therapy products into patients creates a new layer of responsibility and adds to an already demanding list of the existing procedures in academic cGMP facilities. Sponsors introduce their own requirements for the handling of cells that th

SUBMITTER: Sutherland V 

PROVIDER: S-EPMC8368080 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature