Nanda K. Subbarao, PhD

Nanda K. Subbarao, PhD

Group Leader
CMC Development

Nanda Subbarao, PhD joined Biologics Consulting as a Senior Consultant in June 2007.

Prior to Biologics Consulting, she worked for Sandoz (Novartis) in Dayton, NJ as Stability Manager, where she led a group of chemists and sample coordinators/stability administrators for the Research and Commercial Stability Program. She was responsible for stability storage and testing, sample flow, controlled drug substances and Reference Standards. She authored CMC analytical sections for more than 20 products. Some of her key achievements at Sandoz included the improvement of the Stability program cGMP compliance to current standards and the set-up of the sample flow system.

Prior to Sandoz, Nanda worked at Pfizer in St. Louis. She participated on the team to set up cGMP systems for the new Biologics QC Laboratory. Nanda was responsible for the design and implementation of the worksheet system and validated spreadsheets for lab raw data and the upgrade of the laboratory GMP systems from R&D to Commercial GMP level. When the laboratory became operational, she headed the QC lab responsible for electrophoresis and other methods. She eventually became responsible for the Biologics Stability program and led the new cGMP Stability Facility construction and validation teams. She set up the cGMP compliant systems for the Stability Program. Her role also included management of stability studies in contract facilities, preparation and review of CMC Stability sections for Biologics Regulatory submissions from the IND to the Commercial stage.

Nanda has co-authored numerous scientific publications and frequently is an invited speaker at Industry Meetings. As a Senior Consultant with Biologics Consulting, Nanda utilizes her strong technical skills and expertise in Analytical cGMP systems for both biologics and conventional drugs to assist clients in the following aspects of drug development:

  • Set up of cGMP laboratory systems
  • Implementation and management of stability programs
  • Technical and GMP evaluation of a wide variety of analytical methods at all stages of product life cycle
  • Provide technical guidance on method validation for a wide variety of products such as characterized proteins including biosimilars, vaccines, gene therapy products, stem cell products
  • Writing and evaluation of method validation protocols and reports
  • Specification setting
  • CMC analytical sections preparation and review against current regulatory expectations

Education

PhD, Bio-organic Chemistry, Indian Institute of Technology, Bombay (1985)

MS, Chemistry, Indian Institute of Technology, Bombay (1980)

CONTINUING EDUCATION

Obtained training in subjects such as Certified Quality Auditor, Audit Preparation, cGMP Compliance, Project Management and Negotiation skills