Profile: Bingyan Gao is the “ultimate gatekeeper” of peptide purity and quality. He is proficient in the use of various high-end analytical instruments and specializes in developing customized chromatographic separation methods for highly complex modified peptides. He has established a rigorous impurity profiling system that not only ensures product purity of 99% or higher but also precisely identifies and eliminates trace impurities that could cause immunogenicity. With a deep understanding of FDA and EMA regulatory requirements for peptide drugs, he ensures that every batch released from the facility is accompanied by a comprehensive and authoritative Certificate of Analysis (COA).