Dr. Chikkathur Madhavarao
Biologist, CDER-FDA
Dr. Chikkathur N. Madhavarao has a Ph.D., in Biotechnology and after several years of post-doctoral training on a rare genetic disease, has joined FDA in 2009 to understand the impact of production processes on biotherapeutic proteins and product quality attributes (PQAs). He is a Biologist at the Division of Product Quality Research in the Office of Testing and Research, in the Center for Drug Evaluation and Research (CDER), FDA. Using a model for enzyme replacement therapy (ERT) class of therapeutics he has been studying the impact of variation in the metal concentration in the cell culture medium, physical process variations and alterations in media composition on the PQAs of the therapeutic proteins. His current focus is on improving the manufacturing efficiency of protein therapeutics via continuous data acquisition through various process analytical technology (PAT) tools to help produce products with homogeneous PQAs.