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
{"title":"Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment.","authors":"Mark Alasandro,&nbsp;Dilip Choudhury,&nbsp;Kim Huynh-Ba,&nbsp;Jianmei Kochling,&nbsp;Christopher Latoz,&nbsp;Laure Larkin,&nbsp;Lori McCaig,&nbsp;Nanda Subbarao,&nbsp;Yan Wu,&nbsp;Yajie Zhang","doi":"10.1186/s41120-021-00042-1","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":"7 1","pages":"6"},"PeriodicalIF":0.0000,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8632204/pdf/","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"AAPS Open","FirstCategoryId":"1","ListUrlMain":"https://doi.org/10.1186/s41120-021-00042-1","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2021/12/1 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
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.

Abstract Image

Abstract Image

Abstract Image

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
自引率
0.00%
发文量
0
期刊最新文献
Pre-analytical stability of ocrelizumab in serum after delayed centrifugation of whole blood Characterization, stability, and skin application of astaxanthin particulates A controlled vocabulary and taxonomy for the submission of quality attributes for therapeutic proteins An in-silico approach towards multivariate acceptable ranges in biopharmaceutical manufacturing Recent progress of small-molecule of RET inhibitors against Non-small cell lung cancer
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1