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ICH Q5A (R2) On Biologics Viral Safety: The Changes, Challenges & Opportunities

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.

ICH Q5A (R2) aligns global regulatory expectations regarding viral safety of biologics • Source: Shutterstock

Viral vector-derived products. Advanced technologies for detecting contaminating infectious viruses. Novel manufacturing paradigms.

These are just some of the new areas addressed in

About The Author

Manjula Aysola is senior regulatory consultant at MilliporeSigma, the life

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