Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment
| Autor: | Christopher Latoz, Laure Larkin, Nanda Subbarao, Lori McCaig, Kim Huynh-Ba, Yan Wu, Mark Alasandro, Yajie Zhang, Dilip Choudhury, Jianmei Kochling |
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| Rok vydání: | 2021 |
| Předmět: |
Engineering
Stability Modeling Drug Product Transport Freeze-Thaw Study media_common.quotation_subject Pharmacology toxicology Kinetic analysis education RM1-950 Meeting Report Last-Mile Presentation Pharmacy and materia medica Rapid Development Health care Pandemic Vaccine Development media_common business.industry COVID-19 General Medicine Vaccine Stability Rapid Deployment Pharmaceutical Supply Chain RS1-441 Engineering management In-Use Study Software deployment Platform Technologies Shipping Study Therapeutics. Pharmacology business Stability |
| Zdroj: | Aaps Open AAPS Open, Vol 7, Iss 1, Pp 1-9 (2021) |
| ISSN: | 2364-9534 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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