Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment

Abstract The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on “Vaccine Stability Considerations to Enable Rapid Development and Deployment”, on March 24-25, 2021. The workshop included distinguished speakers and panelists from across the...

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Autores principales: Mark Alasandro, Dilip Choudhury, Kim Huynh-Ba, Jianmei Kochling, Christopher Latoz, Laure Larkin, Lori McCaig, Nanda Subbarao, Yan Wu, Yajie Zhang
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Lenguaje:EN
Publicado: SpringerOpen 2021
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Acceso en línea:https://doaj.org/article/a1c20c01b5e340cdb6cab242725d2254
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spelling oai:doaj.org-article:a1c20c01b5e340cdb6cab242725d22542021-12-05T12:11:04ZMeeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment10.1186/s41120-021-00042-12364-9534https://doaj.org/article/a1c20c01b5e340cdb6cab242725d22542021-12-01T00:00:00Zhttps://doi.org/10.1186/s41120-021-00042-1https://doaj.org/toc/2364-9534Abstract The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on “Vaccine Stability Considerations to Enable Rapid Development and Deployment”, on March 24-25, 2021. The workshop included distinguished speakers and panelists from across the industry, academia, regulatory agencies, as well as health care leaders. This paper presents a review of the topics covered. Specifically the challenges in accelerating vaccine development and analytical characterization techniques to establish shelf-life were covered. Additionally, vaccine stability modeling using prior knowledge stability models and advanced kinetic analysis played a key in the EUA approaches discussed during the workshop. Finally, the role of stability studies in addressing the challenges of vaccine distribution and deployment during the pandemic were a focus of presentations and panel discussions. Although the workshop did not have any presentation topics directly dedicated to the mRNA vaccines, the techniques discussed are generally applicable. The mRNA vaccine developers were represented in the panel discussions, where experts involved in the EUA approval/deployment stages for this vaccine type could discuss the challenges as applied to their vaccines.Mark AlasandroDilip ChoudhuryKim Huynh-BaJianmei KochlingChristopher LatozLaure LarkinLori McCaigNanda SubbaraoYan WuYajie ZhangSpringerOpenarticleVaccine DevelopmentCOVID-19StabilityRapid DevelopmentRapid DeploymentLast-MileTherapeutics. PharmacologyRM1-950Pharmacy and materia medicaRS1-441ENAAPS Open, Vol 7, Iss 1, Pp 1-9 (2021)
institution DOAJ
collection DOAJ
language EN
topic Vaccine Development
COVID-19
Stability
Rapid Development
Rapid Deployment
Last-Mile
Therapeutics. Pharmacology
RM1-950
Pharmacy and materia medica
RS1-441
spellingShingle Vaccine Development
COVID-19
Stability
Rapid Development
Rapid Deployment
Last-Mile
Therapeutics. Pharmacology
RM1-950
Pharmacy and materia medica
RS1-441
Mark Alasandro
Dilip Choudhury
Kim Huynh-Ba
Jianmei Kochling
Christopher Latoz
Laure Larkin
Lori McCaig
Nanda Subbarao
Yan Wu
Yajie Zhang
Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment
description Abstract The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on “Vaccine Stability Considerations to Enable Rapid Development and Deployment”, on March 24-25, 2021. The workshop included distinguished speakers and panelists from across the industry, academia, regulatory agencies, as well as health care leaders. This paper presents a review of the topics covered. Specifically the challenges in accelerating vaccine development and analytical characterization techniques to establish shelf-life were covered. Additionally, vaccine stability modeling using prior knowledge stability models and advanced kinetic analysis played a key in the EUA approaches discussed during the workshop. Finally, the role of stability studies in addressing the challenges of vaccine distribution and deployment during the pandemic were a focus of presentations and panel discussions. Although the workshop did not have any presentation topics directly dedicated to the mRNA vaccines, the techniques discussed are generally applicable. The mRNA vaccine developers were represented in the panel discussions, where experts involved in the EUA approval/deployment stages for this vaccine type could discuss the challenges as applied to their vaccines.
format article
author Mark Alasandro
Dilip Choudhury
Kim Huynh-Ba
Jianmei Kochling
Christopher Latoz
Laure Larkin
Lori McCaig
Nanda Subbarao
Yan Wu
Yajie Zhang
author_facet Mark Alasandro
Dilip Choudhury
Kim Huynh-Ba
Jianmei Kochling
Christopher Latoz
Laure Larkin
Lori McCaig
Nanda Subbarao
Yan Wu
Yajie Zhang
author_sort Mark Alasandro
title Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment
title_short Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment
title_full Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment
title_fullStr Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment
title_full_unstemmed Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment
title_sort meeting report: vaccine stability considerations to enable rapid development and deployment
publisher SpringerOpen
publishDate 2021
url https://doaj.org/article/a1c20c01b5e340cdb6cab242725d2254
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