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A Strategic Guide to Improve and De-Risk Vaccine Development: CEPI's CMC Framework
Anna Särnefält1, Ranna Eardley-Patel2, Diletta Magini2
1Coalition for Epidemic Preparedness Innovations (CEPI), 0218 Oslo, Norway anna.sarnefalt@cepi.net.
Abstract:
The Coalition for Epidemic Preparedness Innovations (CEPI) has developed a robust CMC (Chemistry, Manufacturing, and Controls) Framework to enhance the likelihood of successful vaccine development. This Framework serves as a comprehensive guide, aiding developers in building effective strategies to overcome the challenges posed by the different phases of vaccine development, including the ones often referred to as the "valleys of death". The Framework lists stage-appropriate deliverables, categorized and refined, spanning five key areas: manufacturing process, formulation and stability, analytics, supply chain, and compliance. By emphasizing the critical aspects of CMC development, CEPI's objective is to expedite the progression of vaccine candidates from research to deployment, reducing delays, mitigating risks, and optimizing the overall development process, all while upholding uncompromising quality standards, ultimately increasing the probability of success.
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