The manufacturing and supply chain division oversees and advises on the development, manufacturing and quality control of vaccine candidates and biologicals, ensuring they comply with regulations and are safe and effective for use and are fit-for-purpose to deliver on CEPI's mission.
CMC Rapid Response Framework
We have developed this CMC (Chemistry, Manufacturing and Controls) rapid response framework to support accelerated vaccine development, manufacturing, and roll-out for various outbreak scenarios to achieve the 100 Days Mission. The framework outlines coordinated deliverables across five functional areas: manufacturing processes, formulation, analytics, supply chain, and facilities. It could serve as a tool to streamline CMC and the related activities for rapid vaccine development, identify areas for improvement and innovation, and assess preparedness for the outbreak response. The framework emphasizes the importance of thorough preparation during interpandemic periods as the foundation for the 100 Days Mission and for gaining the confidence of health authorities and the public in vaccines.
The publication describing the CMC rapid response framework can be found here:
Fast-Tracking Vaccine Manufacturing: CEPI’s Rapid Response Framework for the 100 Days Mission. Kim J, Sabet-Azad R, Patel D' Malin G, Askary SH, Särnefält A. Vaccines 2025, 13, 849.
We have developed a robust CMC 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.
The publication describing the CMC framework can be found here:
A Strategic Guide to Improve and De-risk Vaccine Development: CEPI’s CMC Framework Anna Sarnefalt, Ranna Eardley-Patel, Diletta Magini, et al. Journal of Pharmaceutical Science and Technology July 2024, Vol 28, issue 4.
This guidance has been written to facilitate and provide CMC technical support for the tech transfer of vaccines manufacturing and analytical methods between development and manufacturing team OR between 2 manufacturing sites as per cGMP and QMS. Knowledge transfer includes development history, process knowhow, control strategies, process validation methods and strategies for the continuous improvement.
