- NICEATM Site
- Download Report
- Contact Us
Biologics are products derived from biological sources and used as medicines in humans or animals. Biologics can include viruses, substances derived from blood and serum, toxins, antitoxins, vaccines, and large polypeptides.
Regulatory agencies such as the FDA and USDA require batch testing of some biologics. While the specific testing requirements vary among agencies, this testing may be used to develop appropriate labeling, ensure potency of the product when used as labeled, and/or evaluate the safety and potency of manufactured vaccines prior to sale. Some of this testing can use many animals and cause the animals pain and distress. ICCVAM agencies are exploring approaches to reduce or eliminate the need for animal testing for biologics.
USDA: Exemptions to Reduce Live Animal Use in Leptospira Vaccine Potency Testing
Leptospirosis is a transmissible bacterial disease of animals and humans caused by infection with any of the pathogenic members of the genus Leptospira. The organism is shed in the urine and milk of infected animals; infection can cause liver or kidney damage that can be fatal. Disease transmission to man and animals is reduced by the vaccination of cattle, swine, and dogs. Testing to determine vaccine potency is required by law.
In April 2017, the USDA Animal and Plant Health Inspection Service Center for Veterinary Biologics (CVB) issued CVB Notice 17-06, Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Pomona and Grippotyphosa. This exemption to the test codified in 9 CFR 113 §101-104 can reduce animal use up to 50 percent for testing vaccines for these Leptospira serogroups. CVB Notice 17-06, along with the 2015 CVB Notice 15-13, Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Canicola and Icterohaemorrhagiae are available on the USDA website.
CVB Notice 17-06 is the latest action in a continuing effort by USDA to reduce the number of hamsters required for potency testing of leptospirosis vaccines. In addition, CVB has started to ship cryopreserved leptospirosis challenge cultures to manufacturers upon request. Cryopreserved cultures reduce the number of live animal passages to maintain the virulence of the challenge organisms.