Veterinary biologics (veterinary vaccines, antiserums, immune modulators) are those products used to prevent, diagnose, or treat animal diseases which achieve their primary effect through immune stimulation or immune modulation. Notably, this mechanism of action distinguishes veterinary biologics (veterinary immuno-biologics) from veterinary medical drugs or veterinary devices. Veterinary biologics are regulated under the oversight of the United States Department of Agriculture – Center for Veterinary Biologics (USDA-CVB).
Examples of Veterinary Biologics include:
-Antiserums
-Antivenoms and antitoxins
-Antibody products
-Allergen extracts
-Bacterins and toxoids
-Diagnostic kits (with exceptions)
-Immune stimulants
-Immune modulators
-Veterinary vaccines
-Veterinary cancer vaccines
Veterinary Biologics
Woods Consulting, LLC can assist companies in regulatory and development strategies concerning veterinary vaccines, veterinary diagnostics, veterinary immune modulators, veterinary cancer vaccines, and other veterinary products which are regulated as veterinary biologics under the United States Department of Agriculture.
Veterinary Biologic Products must satisfy safety, efficacy, potency and purity for licensure.
Manufacturing of Veterinary Vaccines, Antiserums, Antibodies, and Veterinary Diagnostic Kits: The manufacture and distribution of veterinary immune modulators, biologics, and certain diagnostics are regulated by the United States Department of Agriculture – Animal and Plant Health Inspection Service (USDA-APHIS). These products should be manufactured according to an Outline of Production, which should be conducted according to Good Manufacturing Practices.
Shipment of Experimental Veterinary Vaccines and Biologics: Before shipping experimental veterinary vaccines or biologics for clinical evaluation, the Sponsor should obtain USDA’s authorization to transport (ship), which may include providing the USDA a list of recipients (study sites and investigators). Approval for veterinary immuno-biologics is conducted under the guidance of the USDA-Center for Veterinary Biologics (USDA-CVB).
Veterinary Diagnostics: Veterinary diagnostic kits which are used to diagnose pathogens. These products regulated as biologics by the USDA-APHIS. Examples are point-of-care veterinary diagnostics such as those to test for feline leukemia virus, canine parvovirus, and other viruses, bacteria, and veterinary pathogens. Click here to be redirected to our Veterinary Diagnostics page.
Conditional Licenses: Certain veterinary immuno-biologics may be able to obtain a conditional license if they satisfy specific requirements, including but not limited to reasonable expectations of efficacy, safety and purity.
Veterinary Biologics –
Animal Health Industry Associations and Companies
Association of Veterinary Biologics Companies
Addison Biological Laboratory, Inc.
Ceva Animal Health, LLC
Colorado Serum Company
Immucell
Merck Animal Health
Mg Biologics
Zoetis, Inc.
