Biologics and Vaccine Testing

• Guidance for obtaining an exemption to the requirement for testing Leptospira bacterins for potency in hamsters, Veterinary Services (VS) Memorandum No. 800.102 (2013) -- provides information on alternative in vitro potency assays (SAM) and on reagents available from the Center for Veterinary Biologics (CVB). Use of ELISA is optional. Firms are to obtain an exemption from CVB before using the ELISA. Firms must validate the potency assays for their products and submit data to CVB for acceptance.
• Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Canicola and Icterohaemorrhagiae, CVB Notice #15-13 (2015) -- provides biologic licensees, permitees and applicants the option to remove back-titration hamsters from in vivo potency tests for Leptospira serogroups icterohaemorrhagiae and canicola. CVB would allow an exemption from the titration requirement in vaccination-challenge potency assays for these serogroups Removal of the back-titration hamsters could reduce animal use by 50% when potency testing these two fractions.
• Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Pomona and Grippotyphosa, CVB Notice #17-06 (2017) -- provides biologic licensees, permitees and applicants the option to remove back-titration hamsters from in vivo potency tests for Leptospira serogroups pomona and grippotyphosa. CVB would allow an exemption from the titration requirement in vaccination-challenge potency assays for these serogroups. Removal of the back-titration hamsters could reduce animal use by 50% when potency testing these two fractions.
• Leptospira Bacterin Potency Testing regulations (9 CFR §113.101- 113.105)

Click on the following resources for scientific literature about reduction, refinement or replacement (3Rs alternatives) in leptospirosis vaccine potency testing

• AGRICOLA
• PubMed
• Google Scholar

A list of alternative safety testing methods that are accepted by U.S. and international regulatory authorities. These methods can significantly reduce animal use and improve animal welfare.

This 2002 article describes animal testing characteristics and regulatory framework. It also discusses current trends in the development and implementation of alternatives, particularly in the field of biologicals testing (i.e. vaccine development).

A request for comments, nominations of experts, and submission of data for a proposed workshop on alternative methods to replace the Mouse LD50 Assay for Botulinum Toxin Potency Testing was announced in the Federal Register on January 27, 2006 (Vol. 71, No. 18, pp. 4603-4).