Viral vector-derived products. Advanced technologies for detecting contaminating infectious viruses. Novel manufacturing paradigms.
These are just some of the new areas addressed in ICH Q5A (R2), the guidance that aligns global regulatory...
ICH Q5A (R2) On Biologics Viral Safety: The Changes, Challenges & Opportunities
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Globally harmonized guidance on evaluating the viral safety of biotechnology products has undergone major revisions for the first time in over two decades to address a raft of scientific advances. Manjula Aysola explores the changes and their impact for manufacturers.
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