CMC Framework 

We have 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. 

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. 

https://journal.pda.org/content/early/2024/07/25/pdajpst.2023.012912

The published CMC framework can be downloaded here: 

CEPI_CMC_Framework_published_Sep24_V03.01

CEPI Technical Transfer Guidance  

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.

View the document here: 

Technology Transfer Guidance - CEPI FINAL

Publications 

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 78, issue 4.  https://journal.pda.org/content/early/2024/07/25/pdajpst.2023.012912

Stability Preparedness: The Not-So-Cold Case for Innovations in Vaccine Stability Modelling and Product Release. Franz Schnetzinger, et al. Vaccines 2024, 12(9) https://www.mdpi.com/2076-393X/12/9/1000

Improving vaccine equity by increasing vaccine thermostability. Renske Hesselink et al. Science Translational Medicine, 24 Jul 2024, Vol 16, Issue 757. https://www.science.org/doi/10.1126/scitranslmed.adm7471

The 100 Days Mission: how a new medical-countermeasures network can deliver equity and innovation. Ranna Eadrley-Patel et al. The Lancet October 2023, Volume 402, Issue 10412 p1507-1510. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01775-0/abstract

Availability and use of Standards in vaccine development. Ingrid Kromann, Anna Särnefält et al. npj Vaccines 8, 95 June 2023.  https://www.nature.com/articles/s41541-023-00692-0

Accelerating the development of vaccine microarray patches for epidemic response and equitable immunization coverage requires investment in microarray patch manufacturing facilities. Renske Hesselink et al. Expert Opinion on Drug Delivery, 20(3), 315–322.  https://www.tandfonline.com/doi/full/10.1080/17425247.2023.2168641

Vaccine manufacturing: the future is global. Matthew Downham. Vaccine Insights 2022, 1(6) 293-298. https://www.insights.bio/vaccine-insights/journal/article/2659/Vaccine-manufacturing-the-future-is-global

Sustainable vaccine manufacturing in low- and middle-Income countries. Matthew Downham, et al. Vaccine, Vol 40, Issue 50, Nov 2022 pp 7288-7304. https://www.sciencedirect.com/science/article/abs/pii/S0264410X22013056?via%3Dihub 

Analytical development for rapid response vaccines: start early, think ahead. Sarnefalt, A and Kromann, I. Vaccine Insights 2022; 1(1), 1–3. http://dx.doi.org/10.18609/vac.2022.001

Considerations for the stability of vaccines as liquid-, frozen-, or lyophilized presentations. Ramin Sabet Azad, Raafat Fahim. Vaccine Insights 2022; 1(5), 241–245 https://www.insights-test.bio/vaccine-insights/journal/article/2614/Considerations-for-the-stability-of-vaccines-as-liquid-frozen-or-lyophilized-presentations