A member only survey to benchmark industry experience with replication competent AAV testing. The outcome of the survey will help stimulate further discussion of the topic within the workstream.
A BioPhorum member only summary document detailing consolidated feedback and suggested recommendations from the High-Level Analytics team on MHRA / British Pharmacopoeia: Guidance on the application of vector copy number for the cell and gene therapy community​.
Summary of member feedback and recommendations on British Pharmacopoeia: Guidance on the application of flow cytometry for the cell and gene therapy community. A member only document.
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.