Vaccine manufacturability focused on speed: Call for Proposal

The Call for Proposals (CfP) asks for the submission of a proposal for manufacturability-related innovations and technologies that can accelerate the time required to make clinical trial material or CTM for emergency use, in response to a new pathogen outbreak. These innovations must optimize processing steps on the critical path towards CTM availability, for any proven vaccine manufacturing platform, and technologies that can be applied to multiple vaccine products and projects. The CfP is divided into four focus areas:

• Focus Area 1: Platform process development in batch or continuous manufacturing mode, process optimization, standardization, and acceleration (such as mRNA, viral vectors, proteins, or other novel platforms are considered).
• Focus Area 2: Analytical technologies that can accelerate drug substance/product batch release and availability of master cell bank (MCB)/ master viral stock (MVS). Rapid technologies for batch release assays exist and new analytical technologies (e.g., identity/potency tests or reagents) will need to be established. These technologies require implementation as part of product licensing.
• Focus Area 3: Innovations to accelerate cell-based manufacturing steps, including synthetic approaches (such as the use of synthetic DNA (deoxyribonucleic acid) for mRNA manufacture). Implementation of cell-free manufacturing innovations (such as cell lysate for protein production) can improve vaccine production.
• Focus Area 4: Any other manufacturing-related innovations that can accelerate CTM availability. The use of Artificial Intelligence (AI) in developing and controlling the manufacturing process can aid in post-approval rapid vaccine deployment.

CEPI will review and evaluate proposals on their merit and in context of stated eligibility and review criteria and CEPI’s overall project portfolio.

This Call is open until 15th December 2023, and a proposal may be submitted at any time between these dates. Submitted proposals will be reviewed in two rounds.