Quality by design modelling to support rapid RNA vaccine production against emerging infectious diseases

Abstract Rapid-response vaccine production platform technologies, including RNA vaccines, are being developed to combat viral epidemics and pandemics. A key enabler of rapid response is having quality-oriented disease-agnostic manufacturing protocols ready ahead of outbreaks. We are the first to app...

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Autores principales:	Damien van de Berg, Zoltán Kis, Carl Fredrik Behmer, Karnyart Samnuan, Anna K. Blakney, Cleo Kontoravdi, Robin Shattock, Nilay Shah
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/07c8cff71bf445a6a6254505e668c398
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id	oai:doaj.org-article:07c8cff71bf445a6a6254505e668c398
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spelling	oai:doaj.org-article:07c8cff71bf445a6a6254505e668c3982021-12-02T17:39:30ZQuality by design modelling to support rapid RNA vaccine production against emerging infectious diseases10.1038/s41541-021-00322-72059-0105https://doaj.org/article/07c8cff71bf445a6a6254505e668c3982021-04-01T00:00:00Zhttps://doi.org/10.1038/s41541-021-00322-7https://doaj.org/toc/2059-0105Abstract Rapid-response vaccine production platform technologies, including RNA vaccines, are being developed to combat viral epidemics and pandemics. A key enabler of rapid response is having quality-oriented disease-agnostic manufacturing protocols ready ahead of outbreaks. We are the first to apply the Quality by Design (QbD) framework to enhance rapid-response RNA vaccine manufacturing against known and future viral pathogens. This QbD framework aims to support the development and consistent production of safe and efficacious RNA vaccines, integrating a novel qualitative methodology and a quantitative bioprocess model. The qualitative methodology identifies and assesses the direction, magnitude and shape of the impact of critical process parameters (CPPs) on critical quality attributes (CQAs). The mechanistic bioprocess model quantifies and maps the effect of four CPPs on the CQA of effective yield of RNA drug substance. Consequently, the first design space of an RNA vaccine synthesis bioreactor is obtained. The cost-yield optimization together with the probabilistic design space contribute towards automation of rapid-response, high-quality RNA vaccine production.Damien van de BergZoltán KisCarl Fredrik BehmerKarnyart SamnuanAnna K. BlakneyCleo KontoravdiRobin ShattockNilay ShahNature PortfolioarticleImmunologic diseases. AllergyRC581-607Neoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENnpj Vaccines, Vol 6, Iss 1, Pp 1-10 (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 Damien van de Berg Zoltán Kis Carl Fredrik Behmer Karnyart Samnuan Anna K. Blakney Cleo Kontoravdi Robin Shattock Nilay Shah Quality by design modelling to support rapid RNA vaccine production against emerging infectious diseases
description	Abstract Rapid-response vaccine production platform technologies, including RNA vaccines, are being developed to combat viral epidemics and pandemics. A key enabler of rapid response is having quality-oriented disease-agnostic manufacturing protocols ready ahead of outbreaks. We are the first to apply the Quality by Design (QbD) framework to enhance rapid-response RNA vaccine manufacturing against known and future viral pathogens. This QbD framework aims to support the development and consistent production of safe and efficacious RNA vaccines, integrating a novel qualitative methodology and a quantitative bioprocess model. The qualitative methodology identifies and assesses the direction, magnitude and shape of the impact of critical process parameters (CPPs) on critical quality attributes (CQAs). The mechanistic bioprocess model quantifies and maps the effect of four CPPs on the CQA of effective yield of RNA drug substance. Consequently, the first design space of an RNA vaccine synthesis bioreactor is obtained. The cost-yield optimization together with the probabilistic design space contribute towards automation of rapid-response, high-quality RNA vaccine production.
format	article
author	Damien van de Berg Zoltán Kis Carl Fredrik Behmer Karnyart Samnuan Anna K. Blakney Cleo Kontoravdi Robin Shattock Nilay Shah
author_facet	Damien van de Berg Zoltán Kis Carl Fredrik Behmer Karnyart Samnuan Anna K. Blakney Cleo Kontoravdi Robin Shattock Nilay Shah
author_sort	Damien van de Berg
title	Quality by design modelling to support rapid RNA vaccine production against emerging infectious diseases
title_short	Quality by design modelling to support rapid RNA vaccine production against emerging infectious diseases
title_full	Quality by design modelling to support rapid RNA vaccine production against emerging infectious diseases
title_fullStr	Quality by design modelling to support rapid RNA vaccine production against emerging infectious diseases
title_full_unstemmed	Quality by design modelling to support rapid RNA vaccine production against emerging infectious diseases
title_sort	quality by design modelling to support rapid rna vaccine production against emerging infectious diseases
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/07c8cff71bf445a6a6254505e668c398
work_keys_str_mv	AT damienvandeberg qualitybydesignmodellingtosupportrapidrnavaccineproductionagainstemerginginfectiousdiseases AT zoltankis qualitybydesignmodellingtosupportrapidrnavaccineproductionagainstemerginginfectiousdiseases AT carlfredrikbehmer qualitybydesignmodellingtosupportrapidrnavaccineproductionagainstemerginginfectiousdiseases AT karnyartsamnuan qualitybydesignmodellingtosupportrapidrnavaccineproductionagainstemerginginfectiousdiseases AT annakblakney qualitybydesignmodellingtosupportrapidrnavaccineproductionagainstemerginginfectiousdiseases AT cleokontoravdi qualitybydesignmodellingtosupportrapidrnavaccineproductionagainstemerginginfectiousdiseases AT robinshattock qualitybydesignmodellingtosupportrapidrnavaccineproductionagainstemerginginfectiousdiseases AT nilayshah qualitybydesignmodellingtosupportrapidrnavaccineproductionagainstemerginginfectiousdiseases
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Quality by design modelling to support rapid RNA vaccine production against emerging infectious diseases

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