Flow virometry for process monitoring of live virus vaccines-lessons learned from ERVEBO

Abstract Direct at line monitoring of live virus particles in commercial manufacturing of vaccines is challenging due to their small size. Detection of malformed or damaged virions with reduced potency is rate-limited by release potency assays with long turnaround times. Thus, preempting batch failu...

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Autores principales:	Geoffri Ricci, Kevin Minsker, Austin Kapish, James Osborn, Sha Ha, Joseph Davide, Joseph P. Califano, Darrell Sehlin, Richard R. Rustandi, Lawrence W. Dick, Josef Vlasak, Timothy D. Culp, Andreas Baudy, Edward Bell, Malini Mukherjee
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/6fd2905286724233b97e09383c9378da
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spelling	oai:doaj.org-article:6fd2905286724233b97e09383c9378da2021-12-02T14:25:16ZFlow virometry for process monitoring of live virus vaccines-lessons learned from ERVEBO10.1038/s41598-021-86688-z2045-2322https://doaj.org/article/6fd2905286724233b97e09383c9378da2021-04-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-86688-zhttps://doaj.org/toc/2045-2322Abstract Direct at line monitoring of live virus particles in commercial manufacturing of vaccines is challenging due to their small size. Detection of malformed or damaged virions with reduced potency is rate-limited by release potency assays with long turnaround times. Thus, preempting batch failures caused by out of specification potency results is almost impossible. Much needed are in-process tools that can monitor and detect compromised viral particles in live-virus vaccines (LVVs) manufacturing based on changes in their biophysical properties to provide timely measures to rectify process stresses leading to such damage. Using ERVEBO, MSD’s Ebola virus vaccine as an example, here we describe a flow virometry assay that can quickly detect damaged virus particles and provide mechanistic insight into process parameters contributing to the damage. Furthermore, we describe a 24-h high throughput infectivity assay that can be used to correlate damaged particles directly to loss in viral infectivity (potency) in-process. Collectively, we provide a set of innovative tools to enable rapid process development, process monitoring, and control strategy implementation in large scale LVV manufacturing.Geoffri RicciKevin MinskerAustin KapishJames OsbornSha HaJoseph DavideJoseph P. CalifanoDarrell SehlinRichard R. RustandiLawrence W. DickJosef VlasakTimothy D. CulpAndreas BaudyEdward BellMalini MukherjeeNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Geoffri Ricci Kevin Minsker Austin Kapish James Osborn Sha Ha Joseph Davide Joseph P. Califano Darrell Sehlin Richard R. Rustandi Lawrence W. Dick Josef Vlasak Timothy D. Culp Andreas Baudy Edward Bell Malini Mukherjee Flow virometry for process monitoring of live virus vaccines-lessons learned from ERVEBO
description	Abstract Direct at line monitoring of live virus particles in commercial manufacturing of vaccines is challenging due to their small size. Detection of malformed or damaged virions with reduced potency is rate-limited by release potency assays with long turnaround times. Thus, preempting batch failures caused by out of specification potency results is almost impossible. Much needed are in-process tools that can monitor and detect compromised viral particles in live-virus vaccines (LVVs) manufacturing based on changes in their biophysical properties to provide timely measures to rectify process stresses leading to such damage. Using ERVEBO, MSD’s Ebola virus vaccine as an example, here we describe a flow virometry assay that can quickly detect damaged virus particles and provide mechanistic insight into process parameters contributing to the damage. Furthermore, we describe a 24-h high throughput infectivity assay that can be used to correlate damaged particles directly to loss in viral infectivity (potency) in-process. Collectively, we provide a set of innovative tools to enable rapid process development, process monitoring, and control strategy implementation in large scale LVV manufacturing.
format	article
author	Geoffri Ricci Kevin Minsker Austin Kapish James Osborn Sha Ha Joseph Davide Joseph P. Califano Darrell Sehlin Richard R. Rustandi Lawrence W. Dick Josef Vlasak Timothy D. Culp Andreas Baudy Edward Bell Malini Mukherjee
author_facet	Geoffri Ricci Kevin Minsker Austin Kapish James Osborn Sha Ha Joseph Davide Joseph P. Califano Darrell Sehlin Richard R. Rustandi Lawrence W. Dick Josef Vlasak Timothy D. Culp Andreas Baudy Edward Bell Malini Mukherjee
author_sort	Geoffri Ricci
title	Flow virometry for process monitoring of live virus vaccines-lessons learned from ERVEBO
title_short	Flow virometry for process monitoring of live virus vaccines-lessons learned from ERVEBO
title_full	Flow virometry for process monitoring of live virus vaccines-lessons learned from ERVEBO
title_fullStr	Flow virometry for process monitoring of live virus vaccines-lessons learned from ERVEBO
title_full_unstemmed	Flow virometry for process monitoring of live virus vaccines-lessons learned from ERVEBO
title_sort	flow virometry for process monitoring of live virus vaccines-lessons learned from ervebo
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/6fd2905286724233b97e09383c9378da
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Flow virometry for process monitoring of live virus vaccines-lessons learned from ERVEBO

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