A Strategic Guide to Improve and De-Risk Vaccine Development: CEPI's CMC Framework

Area of Science:

• Vaccinology
• Biopharmaceutical Development
• Regulatory Science

Background:

• Vaccine development faces significant hurdles, often termed "valleys of death", leading to delays and failures.
• A structured approach to Chemistry, Manufacturing, and Controls (CMC) is crucial for successful vaccine progression.

Purpose of the Study:

• To introduce the CEPI CMC Framework, a comprehensive guide for vaccine developers.
• To outline stage-appropriate CMC deliverables across key development areas.
• To mitigate risks and expedite vaccine candidate progression from research to deployment.

Main Methods:

• Development of a robust CMC Framework by CEPI.
• Categorization and refinement of stage-appropriate deliverables.
• Focus on five key CMC areas: manufacturing, formulation, analytics, supply chain, and compliance.

Main Results:

• The Framework provides a structured approach to CMC challenges in vaccine development.
• It identifies critical deliverables for each phase of development.
• Emphasis on manufacturing, formulation, analytics, supply chain, and compliance.

Conclusions:

• The CEPI CMC Framework enhances the likelihood of successful vaccine development.
• It aims to reduce delays, mitigate risks, and optimize the development process.
• Upholding quality standards is paramount for successful vaccine deployment.