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In vitro vaccine potency testing: a proposal for reducing animal use for requalification testing.
Developments in Biologicals
|August 15, 2012
Summary
This program eliminates animal use for in vitro potency test requalification by establishing global Standard References. Companies can use these "gold standards" for internal validation, reducing costs and time.
Area of Science:
- Biotechnology
- Veterinary Medicine
- Analytical Chemistry
Background:
- In vitro potency testing in the animal health industry currently requires animal use for requalification.
- Developing and validating company-specific Master Reference Monitoring assays is time-consuming and resource-intensive.
Purpose of the Study:
- To propose a novel program for eliminating animal use in the requalification of in vitro potency tests.
- To establish a global system of Standard References for in vitro assay validation.
Main Methods:
- Development and characterization of Standard References by skilled scientists in global reference laboratories.
- Establishment of a correlation between Standard References and company Master References using internal in vitro assays.
- Utilizing Standard References for qualifying, monitoring, and requalifying company Master References.
Main Results:
- Elimination of animal use for Master Reference requalification.
- Reduction in the need for individual companies to develop and validate extensive monitoring assays.
- Significant decrease in costs and testing time for potency assay requalification.
Conclusions:
- The proposed program offers a viable alternative to animal testing for in vitro potency assays.
- Implementation of Standard References incentivizes the adoption of in vitro methods, enhancing efficiency and reducing ethical concerns.
- This approach provides substantial economic and operational benefits to the animal health industry.
