RT Journal Article
SR Electronic
T1 A Strategic Guide to Improve and De-risk Vaccine Development: CEPI′s CMC Framework
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2023.012912
DO 10.5731/pdajpst.2023.012912
A1 S&aumlrnef&aumllt, Anna
A1 Eardley-Patel, Ranna
A1 Magini, Diletta
A1 Sonje, Vishal
A1 Guzzi, Antonio
A1 Hesselink, Renske
A1 Scotney, Matthew
A1 Lazdins, Alessandro
A1 Chambard, Valerie
A1 Vinnemeier, Christof
A1 Kromann, Ingrid
YR 2024
UL http://journal.pda.org/content/early/2024/07/25/pdajpst.2023.012912.abstract
AB 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.