Core C: Vaccine production and process development

PROJECT SUMMARY - CORE C: VACCINE PRODUCTION AND PROCESS DEVELOPMENT The Vaccine Production and Process Development Core will provide both high-throughput and scalable biologics production and characterization as well as comprehensive process development to support protein- and mRNA-based vaccine development in our Center and the broader ReVAMPP network. Protein production and characterization efforts will leverage the expansive facilities, high-tech equipment, and unique expertise in designed proteins and nanoparticle immunogens at UW's Institute for Protein Design (IPD). In addition to the designed antigens and nanoparticle vaccines produced to support Projects 3-5 of our Center, the Core will produce and provide to the ReVAMPP network high-quality protein reagents such as monoclonal antibodies, viral entry receptors, and benchmark antigens to accelerate vaccine design and evaluation broadly. mRNA vaccine production and characterization will take place in a newly formed mRNA Core Laboratory at the IPD built on cutting-edge equipment and production processes from Quantoom Biosciences, as well as lipid nanoparticle formulation through an ongoing collaboration with Acuitas Therapeutics. Core C will also perform detailed and comprehensive process development on our lead vaccine candidates, building on the IPD's proven track record in translating innovative protein-based medicines and vaccines to industry and government partners. A dedicated team at the IPD will develop the methods, data, and documentation for comprehensive technology transfer packages that will speed preclinical and clinical development of our arenavirus, phenuivirus, and paramyxovirus vaccines. Our team has successfully transferred eight computationally designed protein medicines to industry or government partners for cGMP manufacturing and clinical development, including three nanoparticle vaccines that have all entered clinical trials, one of which, our RBD nanoparticle vaccine for SARS-CoV-2, has been licensed for use in multiple countries. The unique expertise, scale, and capabilities of Core C will be a key component of our Center that, moving forward, will provide a flexible and responsive infrastructure that can rapidly respond to emerging threats.