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Feature Article: Demonstrating Comparability For Well-Characterized Biotechnology Products
By John Towns and Keith Webber
Challenges and approaches in demonstrating comparability of a well-characterized biotechnology product after manufacturing changes can be as varied and complex as the products themselves. Participants at the January 2005 CMC Strategy Forum sought to discuss and agree on common implementation strategies for different manufacturing change scenarios.
Development of flexible, comprehensive approaches in strategy development addressed evaluation of critical product characteristics, appropriate process steps to test, numbers of lots and levels of testing required, and assessment of product comparability (e.g., trending analysis, additional characterization studies, accelerated stability data). The change scenarios we discussed can occur throughout the life-cycle of a product from early development through postapproval manufacturing.
Reprinted With Permission From BioProcess International
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