Title: Advancing CMC QC Testing of Vaccines for Human Use
Date: February 25th
Collaborator: Merck
Description: To date, several different vaccine technologies are in use to generate successful vaccines, ranging from conventional viral vaccines to subunit vaccines, viral vector vaccines, and mRNA vaccines. Based on the bioprocess used to manufacture a vaccine and its associated Chemistry, Manufacturing, and controls (CMC) risks, the relevant Quality Control (QC) testing would be required to be performed for quality assurance. Globally, viral vaccines still make up a substantial portion of the total vaccines administered. It’s estimated that viral vaccines represent around 70-80% of all vaccines administered globally. This estimate includes both routine immunizations and pandemic responses. CMC QC testing to support the manufacturing of viral vaccines can encounter challenges such as test article inference, availability of neutralizing antisera, wide range of cell substrate, and species-specific viruses. The coming of age of Next Generation Sequencing (NGS) analysis and other advanced methods to support CMC QC testing can help address these challenges. One example of such advanced molecular method is the degenerate PCR-based detection platform which will also be covered in this presentation.
Speaker: Dr. Edmund Ang, and Dr. Feng Huixing
In this webinar, you will learn:
- What needs to be tested in the production of viral vaccine;
- Points to consider and challenges with less commonly used production cells and test samples containing viruses; and
- How advanced molecular methods such as NGS and degenerate PCR-based technologies, supported by current regulatory guidance, can advance CMC QC testing of viral vaccines.
