December 15, 2021-
Extractables and leachables testing for combination products

Extractables and leachables testing is an essential and integral part of qualifying combination product packaging and delivery systems during drug development. With combination products, there are typically multiple elements that comprise the device and/or packaging – and all must be meticulously studied to ensure compliance with regulations requiring sufficient data and information to prove that the packaging system chosen maintains the quality, sterility and efficacy of the product. The materials of the combination products packaging may contain extractables that can leach into drug the products and may significantly impact development processes. There are different sources of extractables and leachables that need to be considered and evaluated.

The process of determining an appropriate approach for extractables and leachables testing for a combination product starts with an extractable assessment to understand and ensure all materials are characterized appropriately. During this step it’s very important to set accurately the most critical parameters to be included in the technical assessment.

Leachables testing is a mandatory step for combination products. The assessment is usually performed on real stability samples when available and techinically possible considering the ingredients of the formulation.

During this live webinar we will showcase the most relevant testing challenges, the most appropriate analytical techniques to be employed, the reporting threshold to be applied, the number of check points necessary and all the important information to be shown to regulatory authorities and notified bodies. Our experts will provide valuable insights on how to set-up proper studies, and analysis of extractables and leachables that will serve an essential function during drug and device development.

Thanks to our outstanding experience in the field we will discuss real case studies to help clients understand how extractables and leachables can be most effectively managed through timely and meticulous evaluation and testing.

• Guidelines and regulatory overview impacting combination products
• ISO vs USP
• Chemical characterization of combination products: ISO 10993-18 or pharma approach?
• Critical parameters to be set for the technical assessment
• Design of experiment
• Toxicological evaluation
• Leachables studies:
• Testing challenges
• Analytical techniques to be employed
• Reporting threshold
• Checkpoints to be applied
• How to approach authorities and notified bodies to support regulatory submission
• Case studies:
• Hyaluronic acid in prefilled syringes. The Eurofins Design of the experiment
• Inhalation devices with drug product in cartidges. Which are the E&L testing needed on the different components?
• Q&A

This course offers a rewarding experience and is particularly relevant to the following key figures:

• R&D Manager,
• CQ
• Manager,
• QA Manager,
• Regulatory Manager,
• Production Manager,
• Packaging Manager,
• CMC Manager
• Validation Manager.

Moderator: Paolo Pescio

Simone Carrara

Simone holds a Biotechnology degree from the University of Milan and has a vast experience as bio-analytical researcher, through LC/MS method development for Pharmacokinetics analysis and ADMET profiling. In his previous role as Project Leader he has successfully managed different projects including analytical method development and validation with LC/MS-GC/MS, and drug product impurities characterization. In the last 7 years he has been focusing on extractables & leachables studies to support drugmanufacturing companies to fulfill regulatory requirements. He is currently the E&L Business Unit Manager, in Eurofins BioPharma Product Testing Italy

Daniele Lioi

Senior Consultant at Eurofins Medical Devices Italy