Course Description:Along with clean water and sanitation, vaccines are one of the most effective tools to support global public health. Since 1910 when USP introduced its first smallpox vaccine monograph, USP has developed standards that support the quality and safety of vaccines. As researchers and manufacturers race to develop vaccines to combat COVID-19, demonstrating quality, safety, and efficacy is critical.
Vaccines are developed using several different types of manufacturing platforms. These range from inactivating the pathogens themselves, to production in eggs, and bioreactors. More recently, this has begun to include enzymatic production of mRNA. As a result, tests that ensure quality can vary substantially while core tests (e.g., those that ensure sterility and minimal endotoxins) are usually more standardized and often compendial. This webinar will describe USP standards that support vaccine testing as well as initiatives to develop toolkits that support the assurance of the identity and quality of vaccines in the marketplace. Sample toolkits will be shared in order to receive input from webinar participants.
This “What’s New in Biologics?” webinar is the third in a series that shares the knowledge and expertise from USP staff and world-wide experts on topics that will shape the future of biologics. This event will be hosted live so that participants can submit questions to the speakers. It will then be available for on-demand viewing.
Upon completion of this course, you will be able to
- Identify USP staff and resources that can support analytical method development and validation for the characterization and release of vaccines.
- List USP general chapters and Reference Standards that are commonly used to test vaccines and common raw materials.
- Describe USP’s vaccine toolkits under development.
Who should participate:
- Lab personnel in research and development, manufacturing and production
- Scientists and managers of manufacturing and contract research organizations
- Quality assurance and quality control specialists and auditors
- Regulatory professionals
Speakers
Sarita AcharyaScience & Standards Liaison, Global BiologicsMaura
Kibbey Senior Scientific Fellow, USP Global BiologicsJohn Kokai-Kun Director, USP Global Biologics