This paper outlines strategies for reducing the volumes required for stability studies with the goal of conserving product for patients, while remaining compliant and delivering data on critical quality attributes across the shelf life of gene therapy products. The recommendations provided include considerations for both drug substance and drug product.
batch manufacture
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Minimizing the impact of container closure integrity testing on gene therapy batch yield
Mar 2023 | Cell & Gene Therapy, Commercialization, Deliverable, Deliverables Report, POI - Cell and Gene Therapy, Publication
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.
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>.