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. 2011 Nov 29;1(4):414-32.
doi: 10.3390/ani1040414.

Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods

Samantha Dozier  1 , Jeffrey Brown  2 , Alistair Currie  3
Affiliations

Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods

Samantha Dozier et al. Animals (Basel). .

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: implementation; laboratory animals; non-animal; potency; regulatory testing; safety; vaccine.

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Figures

Figure 1
Figure 1
Generalized bridging paradigm for information-gathering and action.
Figure 2
Figure 2
Application of the bridging paradigm to erysipelas vaccine potency testing in the United States.
Figure 3
Figure 3
Application of bridging paradigm to leptospirosis vaccine potency testing in the United States.
Figure 4
Figure 4
Application of bridging paradigm to clostridial vaccine potency testing and monoclonal antibody production for in vitro potency assays in the United States.
Figure 5
Figure 5
Application of bridging paradigm to NDV vaccine potency testing in the United States.
Figure 6
Figure 6
Application of bridging paradigm to TABST in the United Kingdom and additional jurisdictions
See this image and copyright information in PMC

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