Core C: Vaccine production and process development

NIH Pandemic-Era Grants

Pandemic Era Grants

2024

Document text

Principal Investigator: Lauren  Carter
Organization: UNIVERSITY OF WASHINGTON
Fiscal Year: 2024
Award: $5,637,003
Funding agency: National Institute of Allergy and Infectious Diseases

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.

Terms: <2019-nCoV vaccine><Acceleration><Antibodies><Antigens><Arenaviridae><Arenavirus><Arenavirus group><Assay><B blood cells><B cell><B cells><B-Cells><B-Lymphocytes><B-cell><Benchmarking><Best Practice Analysis><Bioassay><Biologic Sciences><Biological Agent><Biological Assay><Biological Products><Biological Sciences><Bioscience><COVID-19 vaccine><Cell Isolation><Cell Segregation><Cell Separation><Cell Separation Technology><Clinical Treatment Moab><Clinical Trials><Collaborations><Country><Cyclic GMP><Data><Dedications><Development><Disease Outbreaks><Documentation><Equipment><Evaluation><Event><Formulation><Foundations><Funding><Goals><Government><Grippe><Guanosine Cyclic Monophosphate><HIV-1><HIV-I><HIV1><Human Immunodeficiency Virus Type 1><Human Resources><Human immunodeficiency virus 1><In Vitro><Industry><Influenza><Infrastructure><Institution><Laboratories><Laboratory Research><Lead><Licensing><Life Sciences><Machine Learning><Manpower><Medicine><Messenger RNA><Methods><Monoclonal Antibodies><NIAID><National Institute of Allergy and Infectious Disease><Nucleosides><Outbreaks><Pb element><Process><Production><Protein Engineering><Proteins><RNA vaccine><RNA-based vaccine><Reagent><Receptor Protein><Records><Reference Standards><Research Support><SARS Virus><SARS corona virus><SARS coronavirus><SARS-Associated Coronavirus><SARS-CoV><SARS-CoV-1><SARS-CoV-2 vaccine><SARS-Related Coronavirus><SARS-coronavirus-2 vaccine><Scientist><Serology><Severe Acute Respiratory Coronavirus><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe Acute Respiratory Syndrome Virus><Severe Acute Respiratory Syndrome corona virus><Severe Acute Respiratory Syndrome coronavirus><Severe acute respiratory syndrome coronavirus 2 vaccine><Speed><Standardization><Technology Transfer><Testing><Therapeutic><Translating><Translations><Vaccine Design><Vaccine Production><Vaccines><Viral><Work><analytical method><benchmark><beta CoV><beta coronavirus><betaCoV><betacoronavirus><biologics><biopharmaceutical><biotherapeutic agent><cGMP><cell sorting><clinical development><coronavirus disease 2019 vaccine><coronavirus disease-19 vaccine><cost><design><designing><develop a vaccine><develop vaccines><development of a vaccine><developmental><evaluate vaccines><experience><experiment><experimental research><experimental study><experiments><flexibility><flexible><genetic protein engineering><heavy metal Pb><heavy metal lead><immunogen><immunogenicity><in vivo><industrial partnership><industry partner><industry partnership><innovate><innovation><innovative><lipid based nanoparticle><lipid nanoparticle><mAbs><mRNA><mRNA vaccine><mRNA-based vaccine><machine based learning><manufacture><method development><monoclonal Abs><mutation scanning><mutation screening><nCoV vaccine><nCoV-19 vaccine><nCoV19 vaccine><nano particle><nano-sized particle><nanoparticle><nanosized particle><paramyxovirus vaccine><pathogen><personnel><pre-clinical development><preclinical development><produce vaccines><product development><protein design><protein purification><prototype><receptor><severe acute respiratory syndrome-CoV><structural biology><translation><vaccine against 2019-nCov><vaccine against COVID-19><vaccine against SARS-CoV-2><vaccine against SARS-coronavirus-2><vaccine against Severe Acute Respiratory Syndrome CoV 2><vaccine against Severe acute respiratory syndrome coronavirus 2><vaccine candidate><vaccine candidates against SARS-CoV-2><vaccine development><vaccine evaluation><vaccine for novel coronavirus><vaccine screening><vaccine testing><vaccines preventing COVID><vaccines to prevent COVID><β CoV><β coronavirus><βCoV>