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

التفاصيل البيبلوغرافية
العنوان: Development of Robust Freeze-Drying Process for Long-Term Stability of rVSV-SARS-CoV-2 Vaccine.
المؤلفون: Khan MDFH; Viral Vectors and Vaccines Bioprocessing Group, Department of Bioengineering, McGill University, Montreal, QC H2X 1Y4, Canada., Youssef M; Viral Vectors and Vaccines Bioprocessing Group, Department of Bioengineering, McGill University, Montreal, QC H2X 1Y4, Canada., Nesdoly S; Viral Vectors and Vaccines Bioprocessing Group, Department of Bioengineering, McGill University, Montreal, QC H2X 1Y4, Canada., Kamen AA; Viral Vectors and Vaccines Bioprocessing Group, Department of Bioengineering, McGill University, Montreal, QC H2X 1Y4, Canada.
المصدر: Viruses [Viruses] 2024 Jun 11; Vol. 16 (6). Date of Electronic Publication: 2024 Jun 11.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: MDPI Country of Publication: Switzerland NLM ID: 101509722 Publication Model: Electronic Cited Medium: Internet ISSN: 1999-4915 (Electronic) Linking ISSN: 19994915 NLM ISO Abbreviation: Viruses Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Basel, Switzerland : MDPI
مواضيع طبية MeSH: Freeze Drying*/methods , SARS-CoV-2*/immunology , SARS-CoV-2*/chemistry , COVID-19 Vaccines*/immunology , COVID-19 Vaccines*/chemistry , Spike Glycoprotein, Coronavirus*/chemistry , Spike Glycoprotein, Coronavirus*/immunology , Cryoprotective Agents*/chemistry , Cryoprotective Agents*/pharmacology, Trehalose/chemistry ; COVID-19/prevention & control ; COVID-19/virology ; Animals ; Humans ; Mannitol/chemistry ; Sucrose/chemistry ; Vero Cells ; Chlorocebus aethiops ; Sorbitol/chemistry ; Drug Stability ; Histidine/chemistry ; Vesicular stomatitis Indiana virus/genetics ; Vaccines, Synthetic/chemistry ; Vaccines, Synthetic/immunology
مستخلص: The 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.
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معلومات مُعتمدة: RGPIN-2021-02691 Natural Sciences and Engineering Council of Canada; CRC-240394 Canada Research Chair
فهرسة مساهمة: Keywords: COVID-19; CPPs; CQAs; VSV; enveloped viral vector vaccine; freeze-drying; rVSV-SARS-CoV-2; solid formulation; stability; vesicular stomatitis virus; viral vaccine bioprocess
المشرفين على المادة: 0 (COVID-19 Vaccines)
0 (Spike Glycoprotein, Coronavirus)
0 (Cryoprotective Agents)
B8WCK70T7I (Trehalose)
3OWL53L36A (Mannitol)
0 (spike protein, SARS-CoV-2)
57-50-1 (Sucrose)
506T60A25R (Sorbitol)
4QD397987E (Histidine)
0 (Vaccines, Synthetic)
تواريخ الأحداث: Date Created: 20240627 Date Completed: 20240627 Latest Revision: 20240629
رمز التحديث: 20240629
مُعرف محوري في PubMed: PMC11209311
DOI: 10.3390/v16060942
PMID: 38932234
قاعدة البيانات: MEDLINE
الوصف
تدمد:1999-4915
DOI:10.3390/v16060942