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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 U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (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 working to identify methods that will refine existing testing procedures or reduce or replace animal use for biologics testing.
(Photo courtesy of U.S. Centers for Disease Control)