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Comparability studies are a significant issue for those working in biotherapeutics development, as undetected product changes are considered high risk.
Listen to the full episode on Veristat’s Advancing Revolutionary Therapies Podcast to get important insights and recommendations on how to successfully plan your clinical and CMC manufacturing development plans to reduce your regulatory risk along the way.
Learning Points
- The importance of comparability studies for biologics
- Key aspects of a comparability assessment
- How to determine analytical and stability parameters when measuring comparability
- Conditions for evaluating stability studies
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