Designing Effective and Efficient Extractables/Leachables Studies for Biologics

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.

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