Gaya Ratnaswamy, Ph.D.
Dr. Ratnaswamy has over 20 years of experience in the development of parenteral formulations, drug products and analytical methods for a variety of biologics, antibodies, antibody-drug conjugates (ADCs), recombinant proteins and biosimilars.
Prior to joining Pharmefex, Dr. Ratnaswamy served as Director of Analytical and Formulation Development at Agensys Inc, a subsidiary of Astellas Inc for 8 years. She was a key contributor to the development of enfortumab vedotin, an antibody-drug conjugate that has been granted priority review from the FDA. Prior to Agensys, she worked at Amgen Inc for 10 years in the Process and Product Development group where she developed platform formulations for early-stage molecules as well as formulations and lyophilization processes for late-stage products. Dr Ratnaswamy has extensive experience in protein formulation, fill/finish, lyophilization process development, technology transfers to CMOs, analytical comparability, analytical method development, qualifications and transfers to CROs. She also has experience with developing CMC strategy, project planning and authoring regulatory documents.
Dr. Ratnaswamy obtained a Ph.D in Chemistry from Brandeis University working on protein structure determination and completed post-doctoral fellowships at Princeton University and The Scripps Research Institute focusing on the biophysical characterization of proteins.