Senior Scientist (Director)
Bayer Pharmaceuticals

Team Leader
CMC Technical Development Team
Bayer Pharmaceuticals

Dr. Rastogi earned his Ph.D. degree from the North Dakota State University. Dr. Rastogi is focused on Biologics Drug Product (DP) Development and Manufacturing in Biopharmaceutical Industry for the last 20 years. Dr. Rastogi has been involved in Product development, Formulation development, Process development, Clinical manufacturing, Conformance manufacturing/ Validation, Regulatory submission & response, Pre [1] Approval Inspection, Approval & Launch, and Process transfer of Biologics Drug Product. He has successfully led Manufacturing Process development for several Biologics Drug Products including monoclonal antibodies (mAb), and is considered a trusted Subject Matter Expert on Drug Product Development and Manufacturing related matters. Dr. Rastogi has published more than 40 research papers /review articles (in key journals including Pharmaceutical Research, and International Journal of Pharmaceutics), Bayer internal peer-reviewed scientific research papers, and has extensively presented the research in national and international conferences.

Topic of talk: Antibody Drug Product Formulation Development