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Principles of vaccine potency assays
Thorsten Verch1, Jeremiah J Trausch1, Mary Shank-Retzlaff1
1Vaccines Analytical Development, Merck & Co., Inc., West Point, PA 19486, USA.
Bioanalysis
|January 16, 2018
Summary
Developing effective vaccine potency assays is crucial for ensuring vaccine quality and safety. Modern analytical methods offer alternatives to traditional animal testing, enabling lot-to-lot consistency for diverse vaccine types.
Area of Science:
- Vaccinology
- Analytical Chemistry
- Immunology
Background:
- Vaccine potency assays present unique challenges compared to biologics due to complex compositions and global distribution.
- Traditional in vivo assays, while historically used, are being replaced by modern analytical techniques.
Purpose of the Study:
- To explore modern analytical methods for vaccine potency testing.
- To demonstrate the link between a vaccine's mechanism of action and the appropriate potency assay selection.
- To provide guidance for selecting suitable potency assays.
Main Methods:
- Review of historical and modern analytical techniques for vaccine potency assessment.
- Analysis of case studies linking vaccine mechanism of action to assay choice.
- Development of a decision tree for potency assay selection.
Main Results:
- Modern vaccines utilize biochemical, cell-based, and immunochemical methods for potency determination.
- Cell-based assays are essential for live vaccines to ensure infectivity.
- Immunoassays are effective for monitoring recombinant vaccine potency.
Conclusions:
- Assay selection for vaccine potency is critically dependent on the vaccine's mechanism of action and the need for lot-to-lot consistency.
- Modern analytical approaches offer more precise and efficient alternatives to traditional in vivo methods.
- A decision-making framework aids in choosing the most appropriate potency assay.
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