USP Developing Standards for Therapeutic Proteins

The U.S. Pharmacopeial Convention (USP) is developing standards for therapeutic proteins to help manufacturers in the development and analysis of their proteins. USP’s standards for these and other biologics are based on input from global scientific experts and on specifications for FDA-approved products. Published in the United States Pharmacopeia—National Formulary (USP–NF), the standards (monographs and general chapters) “provide comprehensive information, validated methods, and approved quality specifications, USP says, adding that USP–NF standards “are frequently accompanied by associated Reference Standards available for use in method development, validation and testing.”

Examples of recent protein general chapters and associated reference standards include the following:USP General Chapter <129> Analytical Procedures of Recombinant Therapeutic Monoclonal AntibodiesUSP General Chapter <212> Oligosaccharide AnalysisUSP General Chapter <507> Protein Determination Procedures