Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
News|Articles|May 14, 2024
Addressing the complex demands of cell line development
Author(s)Bora Pharmaceuticals
Having a robust Cell Line Development (CLD) strategy is the foundation of biologic production that can propel a project, helping to streamline production while mitigating risk. A tailored and optimized cell line can be instrumental in overcoming development and manufacturing challenges and achieving a competitive advantage in the market with streamlined manufacturing processes. In this eBook, Bora Biologics describes how a robust CLD strategy can help biologics developers anticipate and overcome challenges and streamline production.
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