Issue Date: June 24, 2024
Issued by: Center for Veterinary Medicine
Topic(s): Premarket, Biotechnology, Chemistry, Manufacturing, and Controls (CMC), Investigational New Animal Drug (INAD), New Animal Drug Application (NADA)
Status: Draft
CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use
Recombinant proteins are produced with recombinant deoxyribonucleic acid (DNA) technology. The production of recombinant proteins has unique characteristics; therefore, the information related to manufacture, characterization, and stability may differ from published guidances specific to synthetic chemical substances. This guidance describes the Center for Veterinary Medicine’s recommendations for the information to be included in Chemistry, Manufacturing, and Controls submissions to New Animal Drug Applications, Conditional New Animal Drug Applications, Investigational New Animal Drug files, and Veterinary Master Files specific to recombinant protein-based intermediates, drug substances, and drug products.
Download the Guidance Document
