Standards-Setting Activities on Impurities

Composition of the advisory Expert Panel includes representatives from pharmaceutical and over-the-counter (OTC) product manufacturers and their trade groups (i.e., the Consumer Healthcare Products Association, Pharmaceutical Research and Manufacturers of America, and others), members of USP's Expert Committees on Physical Analysis, Small Molecules and Toxicology, and liaisons from FDA. RESIDUAL DNA AND HOST-CELL PROTEINS Although traditional small-molecule drugs are made through chemical synthetic routes, many biologic and biotechnology products are made using recombinant technologies in host cells designed to produce a genetically engineered therapeutic protein.