Chen Li, PhD, is Director of Analytical Sciences at ProtaGene. She oversees mass spectrometry (MS)-based work at ProtaGene US, and mainly focuses on applying advanced MS-based approaches to help the development of complex biologic drugs, including protein-based therapeutics, gene therapies, and other new biological entities. She has more than 10 years of professional experience in providing analytical development solutions, including process development, structure characterization, comparability analysis, and stability studies for CMC and regulatory filings. In the past five years, Dr. Li’s team developed LC-UV-MS assays to support the development of various AAV gene therapy products, including capsid ratio, primary structure, PTMs and host cell protein (HCP) analysis. The team also established LC-MS assays to monitor expressed proteins from administered gene therapy products in vitro and in vivo. Before the merger, Dr. Li served as Director of Analytical Sciences at BioAnalytix, where she led the development of advanced MS-based methods to characterize complex biologic drugs. Dr. Li received her PhD in Analytical Chemistry from Northeastern University at the Barnett Institute, where she researched protein structures by LC-MS. |