Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use; Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #288 entitled "Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use." This draft guidance describes the FDA Center for Veterinary Medicine's (CVM) recommendations for the information that should be included in Chemistry, Manufacturing, and Controls (CMC) submissions to New Animal Drug Applications (NADAs), Conditional New Animal Drug Applications (CNADAs), Investigational New Animal Drug (INAD) files, and Veterinary Master Files (VMFs) specific to recombinant protein-based intermediates, drug substances, and drug products. Recombinant proteins are produced with recombinant deoxyribonucleic acid (DNA) technology. The production of recombinant proteins has unique characteristics; therefore, the recommended information related to manufacture, characterization, and stability may differ from other FDA guidances specific to synthetic chemical substances.