Biotech 2012 - Designing Effective and Efficient Extractables/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.

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.