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Vaccine Production01:23

Vaccine Production

144
Vaccine production involves a sequence of upstream and downstream processes to generate a safe and effective immunological product. It begins with cultivating microorganisms, such as viruses or bacteria, to obtain antigenic material. For viral vaccines, mammalian host cells are grown in bioreactors and subsequently infected with the target virus. The virus replicates within the host cells, which are lysed to release viral particles. This lysate is then clarified through filtration or...
144

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Fast-Tracking Vaccine Manufacturing: CEPI's Rapid Response Framework for the 100 Days Mission.

June Kim1, Ramin Sabet-Azad1, Dimki Patel1

  • 1Manufacturing & Supply Chain, Coalition for Epidemic Preparedness Innovations, Askekroken 11, 0277 Oslo, Norway.

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Summary
This summary is machine-generated.

The Coalition for Epidemic Preparedness Innovation (CEPI) developed a rapid response framework to accelerate vaccine development and manufacturing for outbreaks. This framework streamlines activities and enhances preparedness for the 100 Days Mission.

Keywords:
100 Days MissionChemistry, Manufacturing and Controls (CMC)accelerated vaccine developmentpandemic preparednessplatform technologiesrapid response framework

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Area of Science:

  • Vaccinology and Pharmaceutical Sciences
  • Epidemic Preparedness and Response
  • Manufacturing and Supply Chain Management

Background:

  • The Coalition for Epidemic Preparedness Innovation (CEPI) aims to accelerate vaccine development for emerging infectious diseases.
  • A critical component for rapid vaccine deployment is a robust Chemistry, Manufacturing, and Controls (CMC) strategy.
  • Existing frameworks may not adequately address the speed and coordination required for pandemic-level responses.

Purpose of the Study:

  • To introduce and describe CEPI's CMC rapid response framework.
  • To outline the framework's structure and key functional areas for accelerated vaccine development.
  • To highlight the framework's utility in preparing for and responding to outbreak scenarios, specifically the 100 Days Mission.

Main Methods:

  • Development of a structured framework encompassing five key CMC functional areas.
  • Identification of coordinated deliverables across manufacturing processes, formulation, analytics, supply chain, and facilities.
  • Emphasis on interpandemic preparedness to ensure readiness for rapid response.

Main Results:

  • The framework provides a systematic approach to streamline CMC activities for vaccine development.
  • It identifies critical areas for improvement and innovation within the vaccine manufacturing and supply chain.
  • The framework serves as a tool to assess and enhance preparedness for outbreak scenarios.

Conclusions:

  • CEPI's CMC rapid response framework is a vital tool for achieving the 100 Days Mission.
  • Thorough interpandemic preparation is foundational for effective outbreak response and public trust in vaccines.
  • The framework supports coordinated efforts in vaccine development, manufacturing, and roll-out.