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Your comprehensive biologics management solution is engineered to address the unique challenges of people, processes & patients innovatively The life cycle of analytical methods plays a critical aspect of biological product development The successful development of biologics requires cmc development along with clinical development, including ensuring the readiness of manufacturing facilities for commercial production

Explore the full cell bank lifecycle for biologics and cell & gene therapies—from rcb to eopcb Lifecycle management must account for bioprocess adjustments across biologics to address contamination and stability, ensuring ongoing compliance with regulatory expectations scaling up Learn gmp best practices, testing strategies, and regulatory insights to support robust manufacturing and successful bla/maa submissions.

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Guidelines focus on lifecycle management the biomanufacturing industry’s increased attention to lifecycle management has been driven by management and mitigation as a result of the fda’s “pharmaceutical cgmps for the 21st century” initiative Assays conducted at several stages of a biologic’s lifecycle include assessment of both protein and drug product stability

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