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Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods
People for the Ethical Treatment of Animals, 501 Front Street, Norfolk, VA 23510, USA
People for the Ethical Treatment of Animals Foundation, P.O. Box 36678, London, SE1 1YE, UK
* Author to whom correspondence should be addressed.
Received: 29 October 2011; in revised form: 19 November 2011 / Accepted: 22 November 2011 / Published: 29 November 2011
Simple Summary: Many vaccines are tested for quality in experiments that require the use of large numbers of animals in procedures that often cause significant pain and distress. Newer technologies have fostered the development of vaccine quality control tests that reduce or eliminate the use of animals, but the availability of these newer methods has not guaranteed their acceptance by regulators or use by manufacturers. We discuss a strategic approach that has been used to assess and ultimately increase the use of non-animal vaccine quality tests in the U.S. and U.K.
Abstract: In recent years, technologically advanced high-throughput techniques have been developed that replace, reduce or refine animal use in vaccine quality control tests. Following validation, these tests are slowly being accepted for use by international regulatory authorities. Because regulatory acceptance itself has not guaranteed that approved humane methods are adopted by manufacturers, various organizations have sought to foster the preferential use of validated non-animal methods by interfacing with industry and regulatory authorities. After noticing this gap between regulation and uptake by industry, we began developing a paradigm that seeks to narrow the gap and quicken implementation of new replacement, refinement or reduction guidance. A systematic analysis of our experience in promoting the transparent implementation of validated non-animal vaccine potency assays has led to the refinement of our paradigmatic process, presented here, by which interested parties can assess the local regulatory acceptance of methods that reduce animal use and integrate them into quality control testing protocols, or ensure the elimination of peripheral barriers to their use, particularly for potency and other tests carried out on production batches.
Keywords: non-animal; vaccine; safety; potency; regulatory testing; laboratory animals; implementation
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Dozier, S.; Brown, J.; Currie, A. Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods. Animals 2011, 1, 414-432.
Dozier S, Brown J, Currie A. Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods. Animals. 2011; 1(4):414-432.
Dozier, Samantha; Brown, Jeffrey; Currie, Alistair. 2011. "Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods." Animals 1, no. 4: 414-432.