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Development of Robust Freeze-Drying Process for Long-Term Stability of rVSV-SARS-CoV-2 Vaccine

dc.contributor.authorMD Faizul Hussain Khan
dc.contributor.authorMaryam Youssef
dc.contributor.authorSean Nesdoly
dc.contributor.authorAmine A. Kamen
dc.contributor.otherViral Vectors and Vaccines Bioprocessing Group, Department of Bioengineering, McGill University, Montreal, QC H2X 1Y4, Canada
dc.contributor.otherViral Vectors and Vaccines Bioprocessing Group, Department of Bioengineering, McGill University, Montreal, QC H2X 1Y4, Canada
dc.contributor.otherViral Vectors and Vaccines Bioprocessing Group, Department of Bioengineering, McGill University, Montreal, QC H2X 1Y4, Canada
dc.contributor.otherViral Vectors and Vaccines Bioprocessing Group, Department of Bioengineering, McGill University, Montreal, QC H2X 1Y4, Canada
dc.date.accessioned2024-06-26T15:39:08Z
dc.date.accessioned2025-10-08T08:24:14Z
dc.date.available2025-10-08T08:24:14Z
dc.date.issued01-06-2024
dc.identifier.urihttp://digilib.fisipol.ugm.ac.id/repo/handle/15717717/35771
dc.description.abstractThe thermostability of vaccines, particularly enveloped viral vectored vaccines, remains a challenge to their delivery wherever needed. The freeze-drying of viral vectored vaccines is a promising approach but remains challenging due to the water removal process from the outer and inner parts of the virus. In the case of enveloped viruses, freeze-drying induces increased stress on the envelope, which often leads to the inactivation of the virus. In this study, we designed a method to freeze-dry a recombinant vesicular stomatitis virus (VSV) expressing the SARS-CoV-2 spike glycoprotein. Since the envelope of VSV is composed of 50% lipids and 50% protein, the formulation study focused on both the protein and lipid portions of the vector. Formulations were prepared primarily using sucrose, trehalose, and sorbitol as cryoprotectants; mannitol as a lyoprotectant; and histidine as a buffer. Initially, the infectivity of rVSV-SARS-CoV-2 and the cake stability were investigated at different final moisture content levels. High recovery of the infectious viral titer (~0.5 to 1 log loss) was found at 3–6% moisture content, with no deterioration in the freeze-dried cakes. To further minimize infectious viral titer loss, the composition and concentration of the excipients were studied. An increase from 5 to 10% in both the cryoprotectants and lyoprotectant, together with the addition of 0.5% gelatin, resulted in the improved recovery of the infectious virus titer and stable cake formation. Moreover, the secondary drying temperature of the freeze-drying process showed a significant impact on the infectivity of rVSV-SARS-CoV-2. The infectivity of the vector declined drastically when the temperature was raised above 20 °C. Throughout a long-term stability study, formulations containing 10% sugar (sucrose/trehalose), 10% mannitol, 0.5% gelatin, and 10 mM histidine showed satisfactory stability for six months at 2–8 °C. The development of this freeze-drying process and the optimized formulation minimize the need for a costly cold chain distribution system.
dc.language.isoEN
dc.publisherMDPI AG
dc.subject.lccMicrobiology
dc.titleDevelopment of Robust Freeze-Drying Process for Long-Term Stability of rVSV-SARS-CoV-2 Vaccine
dc.typeArticle
dc.description.keywordsvesicular stomatitis virus
dc.description.keywordsenveloped viral vector vaccine
dc.description.keywordsfreeze-drying
dc.description.keywordssolid formulation
dc.description.keywordsstability
dc.description.keywordsviral vaccine bioprocess
dc.description.doi10.3390/v16060942
dc.title.journalViruses
dc.identifier.e-issn1999-4915
dc.identifier.oaidfad0cdaa38c463db33ed6f23cf093e6
dc.journal.infoVolume 16, Issue 6


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