The scope of this paper focuses on CCIT of viral vector gene therapy drug product (DP). Cell therapies are out of scope. The strategy proposed here for CCIT is applicable to all advanced therapy medicinal product (ATMP) drug products that are manufactured in small lot sizes, typically <500 vials.
batch manufacture
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Minimize impact of testing: Sterility and bioburden supplementary survey
Feb 2022 | Benchmarking, Cell & Gene Therapy, Commercialization, Deliverable, Deliverables Report
A BioPhorum member survey looking at sterility and bioburden testing during batch manufacture/release testing of gene therapy products within BioPhorum C> member companies. The results are available to members of BioPhorum C>.