A microneedle vaccine printer for thermostable COVID-19 mRNA vaccines

Decentralized manufacture of thermostable mRNA vaccines in a microneedle patch (MNP) format could enhance vaccine access in low-resource communities by eliminating the need for a cold chain and trained healthcare personnel. Here we describe an automated process for printing MNP Coronavirus Disease 2...

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Bibliographic Details
Published in:	Nature biotechnology Vol. 42; no. 3; pp. 510 - 517
Main Authors:	vander Straeten, Aurélien, Sarmadi, Morteza, Daristotle, John L., Kanelli, Maria, Tostanoski, Lisa H., Collins, Joe, Pardeshi, Apurva, Han, Jooli, Varshney, Dhruv, Eshaghi, Behnaz, Garcia, Johnny, Forster, Timothy A., Li, Gary, Menon, Nandita, Pyon, Sydney L., Zhang, Linzixuan, Jacob-Dolan, Catherine, Powers, Olivia C., Hall, Kevin, Alsaiari, Shahad K., Wolf, Morris, Tibbitt, Mark W., Farra, Robert, Barouch, Dan H., Langer, Robert, Jaklenec, Ana
Format:	Journal Article
Language:	English
Published:	New York Nature Publishing Group US 01-03-2024 Nature Publishing Group
Subjects:	631/250/590 639/166/985 639/925/350/354 692/699/255/2514 706/134 Agriculture Automation Bioinformatics Biological activity Biomedical and Life Sciences Biomedical Engineering/Biotechnology Biomedicine Biotechnology Coronaviruses COVID-19 COVID-19 vaccines Fabrication Formulations Immune response Immunization Life Sciences Lipids mRNA mRNA vaccines Nanoparticles Needles Polymer blends Polymers Room temperature Severe acute respiratory syndrome coronavirus 2 Spike protein Vaccines Viral diseases
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Summary:	Decentralized manufacture of thermostable mRNA vaccines in a microneedle patch (MNP) format could enhance vaccine access in low-resource communities by eliminating the need for a cold chain and trained healthcare personnel. Here we describe an automated process for printing MNP Coronavirus Disease 2019 (COVID-19) mRNA vaccines in a standalone device. The vaccine ink is composed of lipid nanoparticles loaded with mRNA and a dissolvable polymer blend that was optimized for high bioactivity by screening formulations in vitro. We demonstrate that the resulting MNPs are shelf stable for at least 6 months at room temperature when assessed using a model mRNA construct. Vaccine loading efficiency and microneedle dissolution suggest that efficacious, microgram-scale doses of mRNA encapsulated in lipid nanoparticles could be delivered with a single patch. Immunizations in mice using manually produced MNPs with mRNA encoding severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein receptor-binding domain stimulate long-term immune responses similar to those of intramuscular administration. Automated fabrication of microneedle patch mRNA vaccines for COVID-19 may improve vaccine access.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Conceptualization: A.V.S., M.S., J.D., M.K., J.C., A.J. and R.F. Methodology: A.V.S., M.S., J.D., M.K., L.T., J.C., A.P., D.V., B.E., J.G., T.F., G.L., N.M., C.J.D., S.L., L.Z., O.P., K.H., S.A. and M.W. Investigation: A.V.S., M.S., J.D., M.K., L.T., J.C., A.P., D.V., B.E., J.G., T.F., G.L., N.M., S.P., C.J.D., S.L., L.Z., O.P., K.H. and M.W. Visualization: A.V.S., M.S., J.D. and J.H. Funding acquisition: A.J., R.L., A.V.S. and M.K. Project administration: A.V.S., J.D., J.C. and A.J. Supervision: A.J., R.L., D.B. and M.T. Writing—original draft: A.V.S., M.S. and J.D. Writing—review and editing: A.V.S., M.S., J.D., L.T., J.H., R.F., D.B., R.L. and A.J. Author contributions
ISSN:	1087-0156 1546-1696 1546-1696
DOI:	10.1038/s41587-023-01774-z