This enlightening event brought together esteemed members of the Extractables and Leachables Safety Information Exchange (ELSIE) consortium for a captivating discussion on the sensitisation potential of extractables and leachables (E&Ls).
Featured presenters and ELSIE consortium members included:
- Patricia Parris, Global Risk Assessment Services Toxicologist at Pfizer
- Geraldine Whelan, Regulatory Toxicologist at GSK
- Martyn Chilton, Principal Scientist at Lhasa Limited
Established in 2007, the ELSIE Consortium unites pharmaceutical, biotechnology, and medical device companies with a shared vision of becoming the leading industry voice and scientific resource on E&Ls.
This exciting webinar entailed:
- Introduction and background:
• Uncover the essence of E&Ls
• Explore their origins and sources
• Understand the traditional risk assessment methodologies
- ELSIE sensitisation framework overview:
• Delve into the ELSIE sensitisation assessment framework
• Explore different routes of administration: dermal, respiratory, parenteral
- Analysis of ELSIE/Product Quality Research Institute (PQRI) databases:
• Constructing a comprehensive database
• Expert review of qualitative sensitisation data
• Prevalence of strong/extreme sensitizers
• Search for and prediction of quantitative sensitisation data
• Plotting quantitative data against established safety thresholds
- Case studies:
• Illustrative case studies for each route of administration: dermal, respiratory, parenteral