National control laboratory independent lot testing of COVID-19 vaccines: the UK experience

Abstract The past 18 months have seen an unprecedented approach to vaccine development in the global effort against the COVID-19 pandemic. The process from discovery research, through clinical trials and regulatory approval often takes more than 10 years. However, the critical need to expedite vacci...

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Autores principales:	Nicola J. Rose, Paul Stickings, Silke Schepelmann, Marc J. A. Bailey, Chris Burns
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/b34105000438424991c08c1643101094
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spelling	oai:doaj.org-article:b34105000438424991c08c16431010942021-12-02T16:28:05ZNational control laboratory independent lot testing of COVID-19 vaccines: the UK experience10.1038/s41541-021-00368-72059-0105https://doaj.org/article/b34105000438424991c08c16431010942021-08-01T00:00:00Zhttps://doi.org/10.1038/s41541-021-00368-7https://doaj.org/toc/2059-0105Abstract The past 18 months have seen an unprecedented approach to vaccine development in the global effort against the COVID-19 pandemic. The process from discovery research, through clinical trials and regulatory approval often takes more than 10 years. However, the critical need to expedite vaccine availability in the pandemic has meant that new approaches to development, manufacturing, and regulation have been required: this has necessitated many stages of product development, clinical trials, and manufacturing to be undertaken in parallel at a global level. Through the development of these innovative products, the world has the best chance of finding individual, or combinations of, vaccines that will provide adequate protection for the world’s population. Despite the huge scientific and regulatory achievements and significant investment to accelerate vaccine availability, it is essential that safety measures are not compromised. Here we focus on the post regulatory approval testing by independent laboratories that provides an additional assurance of the safety and quality of a product, with an emphasis on the UK experience through the National Institute for Biological Standards and Control (NIBSC), an expert centre of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).Nicola J. RosePaul StickingsSilke SchepelmannMarc J. A. BaileyChris BurnsNature PortfolioarticleImmunologic diseases. AllergyRC581-607Neoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENnpj Vaccines, Vol 6, Iss 1, Pp 1-4 (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 Nicola J. Rose Paul Stickings Silke Schepelmann Marc J. A. Bailey Chris Burns National control laboratory independent lot testing of COVID-19 vaccines: the UK experience
description	Abstract The past 18 months have seen an unprecedented approach to vaccine development in the global effort against the COVID-19 pandemic. The process from discovery research, through clinical trials and regulatory approval often takes more than 10 years. However, the critical need to expedite vaccine availability in the pandemic has meant that new approaches to development, manufacturing, and regulation have been required: this has necessitated many stages of product development, clinical trials, and manufacturing to be undertaken in parallel at a global level. Through the development of these innovative products, the world has the best chance of finding individual, or combinations of, vaccines that will provide adequate protection for the world’s population. Despite the huge scientific and regulatory achievements and significant investment to accelerate vaccine availability, it is essential that safety measures are not compromised. Here we focus on the post regulatory approval testing by independent laboratories that provides an additional assurance of the safety and quality of a product, with an emphasis on the UK experience through the National Institute for Biological Standards and Control (NIBSC), an expert centre of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
format	article
author	Nicola J. Rose Paul Stickings Silke Schepelmann Marc J. A. Bailey Chris Burns
author_facet	Nicola J. Rose Paul Stickings Silke Schepelmann Marc J. A. Bailey Chris Burns
author_sort	Nicola J. Rose
title	National control laboratory independent lot testing of COVID-19 vaccines: the UK experience
title_short	National control laboratory independent lot testing of COVID-19 vaccines: the UK experience
title_full	National control laboratory independent lot testing of COVID-19 vaccines: the UK experience
title_fullStr	National control laboratory independent lot testing of COVID-19 vaccines: the UK experience
title_full_unstemmed	National control laboratory independent lot testing of COVID-19 vaccines: the UK experience
title_sort	national control laboratory independent lot testing of covid-19 vaccines: the uk experience
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/b34105000438424991c08c1643101094
work_keys_str_mv	AT nicolajrose nationalcontrollaboratoryindependentlottestingofcovid19vaccinestheukexperience AT paulstickings nationalcontrollaboratoryindependentlottestingofcovid19vaccinestheukexperience AT silkeschepelmann nationalcontrollaboratoryindependentlottestingofcovid19vaccinestheukexperience AT marcjabailey nationalcontrollaboratoryindependentlottestingofcovid19vaccinestheukexperience AT chrisburns nationalcontrollaboratoryindependentlottestingofcovid19vaccinestheukexperience
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National control laboratory independent lot testing of COVID-19 vaccines: the UK experience

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