Considerations for bioanalytical characterization and batch release of COVID-19 vaccines

Abstract The COVID-19 pandemic has prompted hundreds of laboratories around the world to employ traditional as well as novel technologies to develop vaccines against SARS-CoV-2. The hallmarks of a successful vaccine are safety and efficacy. Analytical evaluation methods, that can ensure the high qua...

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Autores principales:	Gautam Sanyal, Anna Särnefält, Arun Kumar
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/5f6edf1c7a8e454ca1b8e855c1504b98
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spelling	oai:doaj.org-article:5f6edf1c7a8e454ca1b8e855c1504b982021-12-02T14:26:25ZConsiderations for bioanalytical characterization and batch release of COVID-19 vaccines10.1038/s41541-021-00317-42059-0105https://doaj.org/article/5f6edf1c7a8e454ca1b8e855c1504b982021-04-01T00:00:00Zhttps://doi.org/10.1038/s41541-021-00317-4https://doaj.org/toc/2059-0105Abstract The COVID-19 pandemic has prompted hundreds of laboratories around the world to employ traditional as well as novel technologies to develop vaccines against SARS-CoV-2. The hallmarks of a successful vaccine are safety and efficacy. Analytical evaluation methods, that can ensure the high quality of the products and that can be executed speedily, must be in place as an integral component of Chemistry, Manufacturing, and Control (CMC). These methods or assays are developed to quantitatively test for critical quality attributes (CQAs) of a vaccine product. While clinical (human) efficacy of a vaccine can never be predicted from pre-clinical evaluation of CQA, precise and accurate measurements of antigen content and a relevant biological activity (termed “potency”) elicited by the antigen allow selection of potentially safe and immunogenic doses for entry into clinical trials. All available vaccine technology platforms, novel and traditional, are being utilized by different developers to produce vaccines against SARS-CoV-2. It took less than a year from the publication of SARS-CoV-2 gene sequence to Emergency Use Authorization (EUA) of the first vaccine, setting a record for speed in the history of vaccine development. The largest ever global demand for vaccines has prompted some vaccine developers to enter multiple manufacturing partnerships in different countries in addition to implementing unprecedented scale-up plans. Quantitative, robust, and rapid analytical testing for CQA of a product is essential in ensuring smooth technology transfer between partners and allowing analytical bridging between vaccine batches used in different clinical phases leading up to regulatory approvals and commercialization. We discuss here opportunities to improve the speed and quality of the critical batch release and characterization assays.Gautam SanyalAnna SärnefältArun KumarNature PortfolioarticleImmunologic diseases. AllergyRC581-607Neoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENnpj Vaccines, Vol 6, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Gautam Sanyal Anna Särnefält Arun Kumar Considerations for bioanalytical characterization and batch release of COVID-19 vaccines
description	Abstract The COVID-19 pandemic has prompted hundreds of laboratories around the world to employ traditional as well as novel technologies to develop vaccines against SARS-CoV-2. The hallmarks of a successful vaccine are safety and efficacy. Analytical evaluation methods, that can ensure the high quality of the products and that can be executed speedily, must be in place as an integral component of Chemistry, Manufacturing, and Control (CMC). These methods or assays are developed to quantitatively test for critical quality attributes (CQAs) of a vaccine product. While clinical (human) efficacy of a vaccine can never be predicted from pre-clinical evaluation of CQA, precise and accurate measurements of antigen content and a relevant biological activity (termed “potency”) elicited by the antigen allow selection of potentially safe and immunogenic doses for entry into clinical trials. All available vaccine technology platforms, novel and traditional, are being utilized by different developers to produce vaccines against SARS-CoV-2. It took less than a year from the publication of SARS-CoV-2 gene sequence to Emergency Use Authorization (EUA) of the first vaccine, setting a record for speed in the history of vaccine development. The largest ever global demand for vaccines has prompted some vaccine developers to enter multiple manufacturing partnerships in different countries in addition to implementing unprecedented scale-up plans. Quantitative, robust, and rapid analytical testing for CQA of a product is essential in ensuring smooth technology transfer between partners and allowing analytical bridging between vaccine batches used in different clinical phases leading up to regulatory approvals and commercialization. We discuss here opportunities to improve the speed and quality of the critical batch release and characterization assays.
format	article
author	Gautam Sanyal Anna Särnefält Arun Kumar
author_facet	Gautam Sanyal Anna Särnefält Arun Kumar
author_sort	Gautam Sanyal
title	Considerations for bioanalytical characterization and batch release of COVID-19 vaccines
title_short	Considerations for bioanalytical characterization and batch release of COVID-19 vaccines
title_full	Considerations for bioanalytical characterization and batch release of COVID-19 vaccines
title_fullStr	Considerations for bioanalytical characterization and batch release of COVID-19 vaccines
title_full_unstemmed	Considerations for bioanalytical characterization and batch release of COVID-19 vaccines
title_sort	considerations for bioanalytical characterization and batch release of covid-19 vaccines
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/5f6edf1c7a8e454ca1b8e855c1504b98
work_keys_str_mv	AT gautamsanyal considerationsforbioanalyticalcharacterizationandbatchreleaseofcovid19vaccines AT annasarnefalt considerationsforbioanalyticalcharacterizationandbatchreleaseofcovid19vaccines AT arunkumar considerationsforbioanalyticalcharacterizationandbatchreleaseofcovid19vaccines
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Considerations for bioanalytical characterization and batch release of COVID-19 vaccines

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