Designing Effective and Efficient Extractables/Leachables Studies for Biologics

• Why test for Extractables Leachables.
• Challenges presented by E/L studies for Biologics.
• Sources of E/L information and how to leverage them.
• Testing for Extractables.
• Testing for Leachables.
• Interpretation of the E/L data.

• R&D Laboratory personnel
• R&D Laboratory Supervisors and Management
• QC Laboratory personnel and management
• Protein Formulation Group personnel and Management
• Regulatory Affairs personnel
• Regulatory Affairs Management
• QC Laboratory personnel and management

Nanda Subbarao, Dr. Subbarao received her Ph.D. in Bio-organic Chemistry from the Indian Institute of Technology, Bombay, India. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from conventional drugs, well characterized proteins, vaccines, cell therapy and gene therapy products, ranging from pre-clinical phase to commercial phases.

She is an ASQ Certified Quality Auditor with expertise in setup of cGMP/GLP complaint Quality Systems for laboratory and stability programs as well as upgrade of existing Quality Systems for products during development and in commercial phase.

She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She serves on the AAPS Stability Focus Group Steering Committee. She also serves on the AAPS National Biotechnology Conference Programming Committee for 2009 to 2011 as the Regulatory Sciences lead.

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