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Topic
Advancing CMC QC Testing of Vaccines for Human Use
Date & Time
Selected Sessions:
Feb 25, 2025 11:00 AM
Description
To date, several different vaccine technologies are in use to develop 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 is required to ensure quality assurance.
Globally, viral vaccines still constitute a substantial portion of the total vaccines administered. It is estimated that viral vaccines represent approximately 70–80% of all vaccines administered worldwide, including both routine immunizations and pandemic responses.
CMC QC testing to support the manufacturing of viral vaccines can present challenges such as test article interference, availability of neutralizing antisera, a wide range of cell substrates, and species-specific viruses. The advent of Next-Generation Sequencing (NGS) analysis and other advanced methods for CMC QC testing can help address these challenges. One example of such an advanced molecular method is the degenerate PCR-based detection platform, which will also be covered in this presentation.
In this webinar, you will learn:
• What needs to be tested in the production of viral vaccines;
• Key considerations and challenges associated 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 enhance CMC QC testing of viral vaccines.