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Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices
Published on: July 14, 2023
Proceedings of the 2019 Viral Clearance Symposium, Session 8. Conference Summary: Key Discussion and Outcomes,
1Amgen, 360 Binney Street, Cambridge MA 02142 gbolton@amgen.com.
Abstract:
This report provides a high-level summary of the key outcomes and gaps based on the research presented at the 2019 Viral Clearance Symposium and identifies new areas for future study and improvements. The 2019 conference structure extended the framework from the preceding conferences, focusing on the key gaps and associated developments and including the additional focus areas of facility risk mitigation, modular viral clearance claims, depth filter viral clearance, retrospective analysis of viral clearance and continuous processing, quantitation and analysis of viral clearance, viral inactivation by detergents and low pH, viral filtration mechanisms, viral filtration of media, viral detection by next-generation sequencing, and ways to improve the efficiency of the overall adventitious agent strategy.
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