Register interest

Agenda

Registration & welcome refreshments
Chair's opening remarks
The ELSIE Knowledge Base
A novel research tool to advance collaboration on safety and extractables evaluation
Session 1: E&L Case Studies
Sample preparation methodologies to enable determination of semi-volatile and non-volatile leachables at low Analytical Evaluation Threshold (AET) in biopharmaceutical products
Interactions of formaldehyde and acetaldehyde on human derived coagulation factor IX
Alicja Sobantka I Corporate Operational Excellence and Support I Octapharma
Janine Janoušek I Expert Material Qualification I Octapharma

 
Panel discussion: pharma and biotech share experiences with E&L studies for different product categories

Petra Booij | Investigator, Structure and Function Characterization, Analytical Development, GSK
Jason Creasey I Managing Director I Maven E&L Ltd.

Thomas Egert | Research Scientist Pharmaceutical Contact Materials | Boehringer Ingelheim
Alicja Sobantka I Corporate Operational Excellence and Support I Octapharma

Networking Break
Session 2: Single-Use Systems
Workflow for identifying and monitoring antioxidant additives in single-use systems
The single-use system dilemma - a case study

Asger W. Nørgaard MSc PhD | Senior Research Scientist, CMC Analytical Support, Novo Nordisk A/S
Carsten Worsøe | Principal Scientist Extractables and Leachables, Novo Nordisk A/S

Clearance of bioprocess equipment leachables via tangential flow filtration
Networking Lunch
Session 3: Medical Devices
Chemical characterization and non-targeted analysis of medical device extracts: what’s next?
Chemical characterisation of medical devices from a Notified Body perspective
Endpoint determination of exhaustive extractions in medical device E&L studies – challenges, expectations and reality
Networking break
E&L studies for long-term implants: extractability, identification and concentration
Leveraging or strengthening medical devices analytical chemistry set of data to derisk drug combination product submission
Chair's Day One Summary
Networking Drinks Reception
Registration & Welcome Refreshments
The role of uncertainty in E&L
Avoiding making perfect the enemy of the good enough
Session 4: Toxicology
Emerging applications of computational methods in the assessment of extractables and leachables
Establishing Permitted Daily Exposure (PDE) Values for Extractables & Leachables in Drug Products
Update on ELSIE Framework for sensitisation assessment of E&Ls and practical application
Nitrosamines as leachables in parenteral drug products - elephant in the room or just FUD (fear, uncertainty and doubt)
Networking break
Session 5: Materials
Extractables of silicone components – what are these “Siloxane-related” compounds?
Session 6: Analytical Chemistry
Approaches to address knowns, unknowns and known-unknowns in leachables
Networking Lunch
A comparative study of Electron Spray Ionization (ESI) LC/MS versus Atmospheric Pressure Chemical ionization (APCI) LC/MS on extracts of medical devices
Qualitative extractable and leachable testing using a MS/MS library
Ready-to-use calibrants for extractables & leachables testing methods
Chair's closing remarks and end of conference

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EL-2022-Agenda-29-July

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