2nd Annual Extractables & Leachables Summit 2022

CONFERENCE OVERVIEW

Extractables and leachables (E&L) assessment is a critical part in product development strategy. Regulatory bodies are very concerned about the interaction between pharmaceutical products and container closure systems, drug delivery devices, as well bioprocess manufacturing systems. Therefore, the migration of mobile chemicals from components and ingredients used in drug production and storage needs to be carefully evaluated.

Our online conference brings together scientists, toxicologists and managers to share the latest E&L analytical methods and strategies, regulatory updates and compliance, risk-based E&L programs, chemical characterization and toxicological risk assessment, material selection/screening/identification, uncertainty factors in E&L testing, analytical and safety thresholds, medical device materials and ISO 10993-18, customized methods for specific product types.

Participate in our virtual meeting and equip yourself with new tools to analyze and test for extractables and leachables in biopharmaceutical development - to effectively reduce E&L-related risks and ensure patient safety and product quality.

WE WILL TALK ABOUT

• The toxicological risk assessment for extractables & leachables.
• Derivation of permitted daily exposure limits for individual or groups of E&L substances.
• Identification and sensitivity issues during E&L studies – possible solutions and workarounds.
• Designing effective E&L studies.
• E&L programs to balance costs and turnaround time.
• Emerging data visualization approaches for rapid, heuristic interpretation of highly complex mixtures of structurally and compositionally diverse chemical entities associated with E&L and pharmaceutically relevant materials.
• Challenges in therapeutic biological products.
• Extractables of membrane sterile filters – identification, lessons learned and rinsing recommendation.
• Similarities and differences between medicinal products and medical devices for extractable and leachable testing.
• E&L risk assessment in bioprocess manufacturing systems.
• PQRI E&L thresholds.
• How to construct a quality risk assessment to define E&L requirements for sus in parenteral processes?
• E&L testing for packaging materials.

WHO IS IT FOR?

CxO, VPs, Directors, Heads, Managers of

• Extractables and Leachables/ E&L
• Analytical Chemistry/ Analytical Development/Analytical Science
• Product Characterisation/ Risk Assessment
• Drug Development/ Drug Substance
• Drug Safety/ Compound Safety/ Toxicology
• Device Development/ Device Engineering/Container Development
• Good Laboratory Practice (GLP)/Good Manufacturing Practice (GMP)
• Manufacturing Science & Technology/ Single Use Systems
• Bioprocessing/ Bioproduction
• Regulatory Affairs & Compliance
• Materials Science/ Materials Selection/ Biocompatibility
• Packaging & Labelling
• LC-MS/ Mass Spectrometry

[Agenda] 2nd Annual Extractables & Leachables Summit 2022

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.