Q&A

Differences, Challenges And Best Practices For Manufacturing Of Biologics Under GMP Compliance

Source: Polyplus

By Jeffrey Lacouchie, Regulatory Affairs Specialist, Polyplus

Scientists laboratory GettyImages-640071044

Jeffrey Lacouchie, Regulatory Affairs Specialist at Polyplus discusses everything you always wanted to know about current GMP compliance (but were afraid to ask).  Jeffrey covers topics including the differences between GMPs for solid-dosage products compared to biologics, what challenges should biologics manufacturers be aware of when producing biologics under GMPs, best practices for manufacturing biologics under GMPs, and changes should manufacturers be aware of, specifically for biologics with the EU’s revision to Annex 1.

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