Nanda Subbarao, Ph.D.
Specialties: Analytical, Stability, CMC, GLP/GMP
Biography
Dr. Nanda Subbarao has been a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems since 2007. Prior to that, she was with Sandoz and Pfizer.
Her consulting areas include GMP systems design and implementation focusing on laboratory and stability systems, data integrity and equipment. She has assisted pharma and biotech organizations in evaluation of analytical methods and method validation for a wide range of products from pre-clinical phase to commercial phases. Some specific technical areas include small molecule pharmaceuticals, well characterized proteins including biosimilars and vaccines.
She currently serves as an Editorial Advisor for BioProcess International. Dr. Subbarao holds a Ph.D. in Bio-organic Chemistry from the Indian Institute of Technology.
Recent publications include:
- Parenteral Product Specifications and Stability’ Michael Bergren and Nanda Subbarao, Parenteral Medications, Fourth Edition, Sandeep Nema, John D. Ludwig Ed., CRC Press, 2019.
- ‘The Dangers of Underestimating Method Variability’ PDA Letter, May 3, 2016
- ‘Summary Report of PQRI Workshop on Nanomaterial in Drug Products: Current Experience and Management of Potential Risks’. Jeremy A. Bartlett, Marcus Brewster, Paul Brown , Donna Cabral-Lilly , Celia N. Cruz, , Raymond David , W. Mark Eickhoff , Sabine Haubenreisser , Abigail Jacobs, Frank Malinoski , Elaine Morefield , Ritu Nalubola , Robert Prud’homme , Nakissa Sadrieh , Christie M. Sayes , Hripsime Shahbazian , Nanda Subbarao , Lawrence Tamarkin , Katherine Tyner, Rajendra Uppoor, Margaret Whittaker-Caulk and William Zamboni. AAPS Journal, 2015 Jan;17(1):44-64.
- ‘Impact of Nanoparticle Sterilization on Analytical Characterization’, Nanda Subbarao in Handbook of Immunological properties of Engineering Nanomaterials. edited by Marina Dobrovolskaia & Scott E McNeil. 2013. pp. 53-75.
- ‘Evaluation of Stability Data’, Nanda Subbarao, in Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices. Ed. Kim Huynh-Ba, 2009.