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

AAPS Open Pub Date : 2021-01-01 Epub Date: 2021-12-01 DOI:10.1186/s41120-021-00042-1
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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引用次数: 1

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.

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会议报告:考虑疫苗稳定性以实现快速开发和部署。
美国制药科学家协会(AAPS)稳定性社区于2021年3月24日至25日举办了一次关于“疫苗稳定性考虑因素以实现快速开发和部署”的虚拟讲习班。研讨会包括来自业界、学术界、监管机构以及卫生保健领导者的杰出演讲者和小组成员。本文对所涉及的主题进行了综述。特别是在加速疫苗开发和分析表征技术以建立保质期方面的挑战。此外,在研讨会期间讨论的EUA方法中,使用先验知识稳定性模型和高级动力学分析的疫苗稳定性建模发挥了关键作用。最后,稳定性研究在应对大流行期间疫苗分发和部署挑战方面的作用是介绍和小组讨论的重点。虽然讲习班没有任何直接针对mRNA疫苗的专题介绍,但所讨论的技术是普遍适用的。mRNA疫苗开发商派代表参加了小组讨论,在小组讨论中,参与此类疫苗EUA批准/部署阶段的专家可以讨论其疫苗面临的挑战。
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