Designing Effective and Efficient Extractables or Leachables Studies for Biologics

Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study.

Why Should You Attend:

The FDA industry guidance for container-closure systems for packaging human drugs and biologics requires the testing of container closure components for extractable leachable for all injectibles. Since biologics products are particularly sensitive to leachable there has been increased scrutiny of extractable and leachable associated with biotechnology drug products. The time and resources required for testing for extractable/leachable can be conserved by appropriately planning the study.

This interactive webinar will provide an overview of the steps in a typical Extractables/Leachables study. The literature sources which can preliminary information essential for the plan of a E/L study will be discussed. Gap analysis of such literature leading to the design of an efficient E/L study will be addressed. Steps in an E/L study, handling the data and cases studies will be presented.Practical difficulties encountered by sponsors will be addressed.

Areas Covered in the Seminar:

• 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.

Who Will Benefit:

• 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

Instructor Profile:

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.