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Principal Investigator: Richard Dean Braatz
Organization: MASSACHUSETTS INSTITUTE OF TECHNOLOGY
Fiscal Year: 2022
Award: $500,000
Funding agency: Food and Drug Administration
Project Summary: A modular platform for rapid VLP vaccine development and
manufacturing for SARS-CoV-2 pandemic response
This proposal aims to design, develop, and manufacture a virus-like particle (VLP) vaccine for
SARS-CoV-2, and the techniques developed throughout the work can be applied to accelerate
the vaccine pipeline in response to future pandemics. We will generate a VLP expression system
in a HEK 293 host that efficiently creates a consistent VLP product. This production platform was
designed such that the Spike protein characteristic of SARS-CoV-2 can be easily modified,
allowing the vaccine to be modified in response to critical viral mutations. The resulting VLP
production system will be scaled up and used for advanced process development. The VLPs will
be generated in perfusion mode, resulting in a more productive platform with a high product yield.
Successful implementation of perfusion processing for a VLP vaccine will enable other VLP based
products to be more rapidly manufactured using a smaller facility footprint, enabling rapid
manufacturing to meet the global demand. Advanced process analytical technology (PAT) will be
applied to fully characterize the process and product, establishing a baseline Critical Quality
Attribute (CQA) profile to ensure a consistently safe and effective product. Data collected during
process development will be used to generate advanced processing models and robust control
strategies for optimal production of the VLP vaccine. This highly collaborative effort will
demonstrate a rapid, streamlined VLP vaccine development and manufacturing process
that can reduce the time to vaccine rollout as new coronaviruses, coronavirus strains, and
other viral pathogens emerge. Not only will the work proposed here generate a vaccine
candidate for SARS-CoV-2, but the methodology described herein will generate a platform
process for response to future pandemics or potential viral mutations.