Ashwinkumar Bhirde, PhD U.S. FDA

Dr. Ashwinkumar Bhirde is a senior research scientist at the Office of Biotechnology Products (OBP), CDER\FDA. Dr. Bhirde has a bachelors and master’s degree in chemical engineering. Dr. Bhirde has a PhD in chemistry from the University of Connecticut. Dr. Bhirde is a primary chemistry, manufacturing, and control reviewer for biotechnology products in OBP. Dr. Bhirde’s regulatory research involves evaluating the pre and post market quality of protein drug products including biosimilars with emphasis on particulate detection, identification and characterization. He is an FDA liaison for USP chapter <788> Particulate Matter in Injections. Dr. Bhirde has participated in cross-lab studies evaluating NIST developed particle standards in the visible and submicron size range.