A BioPhorum member survey to gather preliminary information from across the biopharmaceutical industry on the characterization and risk assessment of HCP using mass spectrometry.
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A BioPhorum member only survey to share knowledge into how, why and when enzymatic activity assays are performed.
Host cell protein risk assessment- Where we are with BioPhorum cross-company collaboration and what we have learnt from an industry perspective?
A presentation on cross-company collaborative work and learnings produced from an industry perspective on host cell protein risk assessment. The presentation included a history of the HCP workstream, previous publications, planned future work and publication plans.
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.