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Published on: February 1, 2017
Release potency tests of hepatitis vaccines
1SmithKline Beecham Biologicals, Rixensart, Belgium.
Developments in Biological Standardization
|November 24, 1999
Summary
SmithKline Beecham Biologicals transitioned to in vitro potency testing for hepatitis A and B vaccines. This shift significantly reduced animal use in vaccine release processes.
Area of Science:
- Vaccinology
- Immunology
- Biotechnology
Background:
- SmithKline Beecham Biologicals developed vaccines for hepatitis A (Havrix, 1991) and hepatitis B (Engerix-B, 1986).
- Traditional vaccine release relied heavily on animal testing for potency assessment.
Purpose of the Study:
- To demonstrate the transition to in vitro potency testing for hepatitis vaccines.
- To highlight the reduction in animal usage for vaccine release.
Main Methods:
- Case study analysis of hepatitis A and B vaccine development and release.
- Evaluation of the implementation of in vitro potency assays.
Main Results:
- The transition to in vitro release testing for vaccine potency was a gradual process.
- Significant reduction in the number of animals required for vaccine release was achieved.
Conclusions:
- In vitro potency testing offers a viable and ethical alternative to animal testing for vaccine release.
- The successful implementation of these methods for hepatitis vaccines demonstrates a pathway for other biological products.
