Using a closure analysis method to reduce CGT contamination risks
Many cell therapy manufacturing processes use open unit manipulations. As a result, they are at risk of potential contam...
Regulatory Strategy
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Challenges for potency assay development for in vivo and ex vivo gene therapies and the matrix approach
This paper highlights some of the challenges to develop potency assays for gene therapies and promotes a potential solution. It seeks to establish Industry alignment on the benefits of a matrix approach and provides high level guidance on how to adopt this strategy towards potency assay development and validation with examples for in vivo and ex vivo GT processes.