{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T19:24:33Z","timestamp":1781292273408,"version":"3.54.1"},"reference-count":60,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T00:00:00Z","timestamp":1759968000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000005","name":"United States Department of Defense","doi-asserted-by":"publisher","award":["W81XWH-18-2-0040"],"award-info":[{"award-number":["W81XWH-18-2-0040"]}],"id":[{"id":"10.13039\/100000005","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background\/Objectives: In response to the COVID-19 pandemic, we developed a vaccine candidate against SARS-CoV-2. Spike Ferritin Nanoparticle (SpFN) comprises 24 identical prefusion-stabilized spike proteins anchored to a self-assembled nanoparticle. Organized along the three-fold axis of the ferritin particle, eight SARS-CoV-2 spike trimers are presented per nanoparticle. Methods: Here, we describe the CGMP processes for manufacturing SpFN using transient transfection of Expi293F cells. Results: The final yield of SpFN was ~10 mg per liter of media supernatant. The resulting protein is stable in cold storage for two years at \u221220 \u00b0C, as well as for a month at room temperature, and can withstand multiple freeze\/thaw cycles. SpFN material produced using the CGMP protocols adjuvanted with Army Liposomal Formulation-QS-21 (ALFQ) elicited potent neutralizing antibodies against WA-1, Alpha, Beta, and Delta variants in mice as measured by a pseudovirus neutralization assay. Conclusions: This work demonstrates rapid development and scaled-up production of clinical-grade SARS-CoV-2 vaccine protein material, allowing permissive storage and transport conditions, and serves as a framework for recombinant protein production for future emergent pathogens.<\/jats:p>","DOI":"10.3390\/vaccines13101041","type":"journal-article","created":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T16:54:31Z","timestamp":1760028871000},"page":"1041","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Production of Clinical-Grade SARS-CoV-2 Spike Ferritin Nanoparticle Protein Immunogen by Transient Transfection"],"prefix":"10.3390","volume":"13","author":[{"given":"Agnes","family":"Hajduczki","sequence":"first","affiliation":[{"name":"Viral Diseases Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA"},{"name":"Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD 20817, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4967-6426","authenticated-orcid":false,"given":"William C.","family":"Chang","sequence":"additional","affiliation":[{"name":"Viral Diseases Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA"},{"name":"Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD 20817, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rafael","family":"De La Barrera","sequence":"additional","affiliation":[{"name":"Pilot Bioproduction Facility, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James F.","family":"Wood","sequence":"additional","affiliation":[{"name":"Pilot Bioproduction Facility, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei-Hung","family":"Chen","sequence":"additional","affiliation":[{"name":"Viral Diseases Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA"},{"name":"Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD 20817, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7755-7056","authenticated-orcid":false,"given":"Elizabeth J.","family":"Martinez","sequence":"additional","affiliation":[{"name":"Viral Diseases Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA"},{"name":"Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD 20817, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8818-7513","authenticated-orcid":false,"given":"Jaime L.","family":"Jensen","sequence":"additional","affiliation":[{"name":"Viral Diseases Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA"},{"name":"Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD 20817, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajeshwer S.","family":"Sankhala","sequence":"additional","affiliation":[{"name":"Viral Diseases Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA"},{"name":"Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD 20817, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clayton","family":"Smith","sequence":"additional","affiliation":[{"name":"Center for Molecular Microscopy, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Frederick, MD 21702, USA"},{"name":"Cancer Research Technology Program, Frederick National Laboratory for Cancer Research, Frederick, MD 21702, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0000-7734","authenticated-orcid":false,"given":"Alexander","family":"Anderson","sequence":"additional","affiliation":[{"name":"Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD 20817, USA"},{"name":"U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elaine B.","family":"Morrison","sequence":"additional","affiliation":[{"name":"U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6087-7301","authenticated-orcid":false,"given":"Caroline E.","family":"Peterson","sequence":"additional","affiliation":[{"name":"Viral Diseases Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA"},{"name":"Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD 20817, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phyllis A.","family":"Rees","sequence":"additional","affiliation":[{"name":"Viral Diseases Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA"},{"name":"Henry M. 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