CEPI is pleased to announce a new funding opportunity for the development of vaccine manufacturability focused on speed.
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.
The main objective is to identify manufacturability opportunities that could accelerate the manufacture of clinical trial material, in response to a new outbreak, and can be rapidly adopted for commercial manufacturing and rapid deployment, to achieve the 100-day mission aspiration. A critical path analysis of different vaccine manufacturing platforms at CEPI (unpublished) identified three areas that can improve the development and manufacture of a new vaccine for first-in-human trials.
I. Platform optimization (making multiple vaccine platforms rapidly adaptable to new pathogens).
II. using synthetic biology approaches for cell free manufacturing of DNA template, proteins and viruses or transient transfection of cell lines at scale for proteins.
III. Rapid analytical testing of drug substance/product, which can reduce hold times between vaccine manufacture and release. This can be achieved through accelerated release testing (especially sterility, adventitious agents, potency tests), incorporation of Process Analytical Technology (PAT) and real-time release,) and implementation of existing but ‘yet to be formally validated’ rapid
For proposal eligibility information, see https://cepi.net/wp-content/uploads/2023/05/Launched_Vaccine-manufacturability-focused-on-speed-Call-for-Proposals.pdf#page=4.
Estimated Total Program Funding: