08.30 – 08.40 h
Introduction
08.40 – 09.40 h
Extractables & Leachables: Regulatory and Scientific Perspectives
- What are Extractables and Leachables?
- Regulatory requirements of EMA and US-FDA
- Compendial requirements
- Scientific aspects
09.40 – 10.40 h
Best Practices for Controlled Extraction Studies
- PQRI recommendations for Extractables studies
- USP <1663> Assessment of Extractables from pharmaceutical packaging systems
- PQRI recommendations and ICH Guidelines: Safety thresholds and Permitted Daily Exposure
10.40 – 11.00 h Break
11.00 – 12.00 h
Q&A Session 1
12.00 – 13.00 h Break
13.00 – 14.00 h
Leachable Studies Design Strategy in Complex Formulated Drugs
- Establishment of Leachables Strategies, the Design Space
- Extractables & Leachables Correlation
- Non-targeted Screening vice versa Validated Target Analysis
- Drug Matrices: Impacts on Leachables Discovery and Identification
- The Large Volume Problem, Analytical Uncertainty, Design Space Solutions
- The Leachables Shelf Life Program
14.00 – 15.00 h
E&L for Single Use Systems as Elements of Process Qualification/Validation and Safety Assessment - Part 1
- Introduction on Single Use Systems (SUS/SUT)
- The Need for E&L Data for SUS in biopharmaceutical processes
- E&L Data for SUS as elements of the qualification triangle
- The concerns with E&L regarding process performance, product quality and patient safety
15.00 – 15.15 h Break
15.15 – 16.00 h
E&L for Single Use Systems as Elements of Process Qualification/Validation and Safety Assessment - Part 2
- Extractables vs. simulation studies for SUS
- Requirements on E&L Data to be suitable for a risk assessment
- The need for extrapolation of SUS extractables data towards process equipment related leachables (PERLs) and towards process conditions
- Modelling approaches as mitigation concepts in the SUS area
16.00 – 16.30 h
Q&A Session 2