Lyophilization to enable distribution of ChAdOx1 and ChAdOx2 adenovirus-vectored vaccines without refrigeration
Distribution of vaccines which require refrigerated or frozen storage can be challenging and expensive. The adenovirus vector platform has been widely used for COVID-19 vaccines while several further candidate vaccines using the platform are in clinical development. In current liquid formulations, a...
| Váldodahkkit: | , , , , |
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| Materiálatiipa: | Journal article |
| Giella: | English |
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Springer Nature
2023
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| _version_ | 1826310935173660672 |
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| author | Zhang, C Berg, A Joe, C Dalby, PA Douglas, A |
| author_facet | Zhang, C Berg, A Joe, C Dalby, PA Douglas, A |
| author_sort | Zhang, C |
| collection | OXFORD |
| description | Distribution of vaccines which require refrigerated or frozen storage can be challenging and expensive. The adenovirus vector platform has been widely used for COVID-19 vaccines while several further candidate vaccines using the platform are in clinical development. In current liquid formulations, adenoviruses require distribution at 2–8 °C. The development of formulations suitable for ambient temperature distribution would be advantageous. Previous peer-reviewed reports of adenovirus lyophilization are relatively limited. Here, we report the development of a formulation and process for lyophilization of simian adenovirus-vectored vaccines based on the ChAdOx1 platform. We describe the iterative selection of excipients using a design of experiments approach, and iterative cycle improvement to achieve both preservation of potency and satisfactory cake appearance. The resulting method achieved in-process infectivity titre loss of around 50%. After drying, there was negligible further loss over a month at 30 °C. Around 30% of the predrying infectivity remained after a month at 45 °C. This performance is likely to be suitable for ‘last leg’ distribution at ambient temperature. This work may also facilitate the development of other product presentations using dried simian adenovirus-vectored vaccines. |
| first_indexed | 2024-03-07T08:00:54Z |
| format | Journal article |
| id | oxford-uuid:b40bc8b8-6362-47a8-b886-54a0e90fd5fc |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T08:00:54Z |
| publishDate | 2023 |
| publisher | Springer Nature |
| record_format | dspace |
| spelling | oxford-uuid:b40bc8b8-6362-47a8-b886-54a0e90fd5fc2023-09-22T14:11:20ZLyophilization to enable distribution of ChAdOx1 and ChAdOx2 adenovirus-vectored vaccines without refrigerationJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:b40bc8b8-6362-47a8-b886-54a0e90fd5fcEnglishSymplectic ElementsSpringer Nature2023Zhang, CBerg, AJoe, CDalby, PADouglas, ADistribution of vaccines which require refrigerated or frozen storage can be challenging and expensive. The adenovirus vector platform has been widely used for COVID-19 vaccines while several further candidate vaccines using the platform are in clinical development. In current liquid formulations, adenoviruses require distribution at 2–8 °C. The development of formulations suitable for ambient temperature distribution would be advantageous. Previous peer-reviewed reports of adenovirus lyophilization are relatively limited. Here, we report the development of a formulation and process for lyophilization of simian adenovirus-vectored vaccines based on the ChAdOx1 platform. We describe the iterative selection of excipients using a design of experiments approach, and iterative cycle improvement to achieve both preservation of potency and satisfactory cake appearance. The resulting method achieved in-process infectivity titre loss of around 50%. After drying, there was negligible further loss over a month at 30 °C. Around 30% of the predrying infectivity remained after a month at 45 °C. This performance is likely to be suitable for ‘last leg’ distribution at ambient temperature. This work may also facilitate the development of other product presentations using dried simian adenovirus-vectored vaccines. |
| spellingShingle | Zhang, C Berg, A Joe, C Dalby, PA Douglas, A Lyophilization to enable distribution of ChAdOx1 and ChAdOx2 adenovirus-vectored vaccines without refrigeration |
| title | Lyophilization to enable distribution of ChAdOx1 and ChAdOx2 adenovirus-vectored vaccines without refrigeration |
| title_full | Lyophilization to enable distribution of ChAdOx1 and ChAdOx2 adenovirus-vectored vaccines without refrigeration |
| title_fullStr | Lyophilization to enable distribution of ChAdOx1 and ChAdOx2 adenovirus-vectored vaccines without refrigeration |
| title_full_unstemmed | Lyophilization to enable distribution of ChAdOx1 and ChAdOx2 adenovirus-vectored vaccines without refrigeration |
| title_short | Lyophilization to enable distribution of ChAdOx1 and ChAdOx2 adenovirus-vectored vaccines without refrigeration |
| title_sort | lyophilization to enable distribution of chadox1 and chadox2 adenovirus vectored vaccines without refrigeration |
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