Qualification of Extractables and Leachables for Combination Products

Drug-device combination products offer patients and healthcare providers convenient access to safe and effective treatments.

However, integrating drugs and devices into a single product introduces unique challenges—particularly in ensuring patient safety through rigorous evaluation of extractables and leachables (E&L). One of the most complex aspects of E&L testing for combination products is aligning the often differing regulatory expectations from both drug and device health authorities.

This webinar will explore the contrasting standards for chemical characterization and toxicological qualification of E&L substances and propose a unified, dual-purpose strategy that satisfies both perspectives.

By integrating ISO 10993-12/-18 and USP <1663>/<1664> for chemical assessment, along with ISO 10993-17 and ICH/PQRI-based frameworks for toxicological qualification, attendees will gain practical guidance on developing a compliant and comprehensive E&L program for combination products. In this webinar, the expert speakers will focus on the following topics:

• Best practices for E&L testing in drug-device combination products
• Approaches to toxicological qualification of leachables using regulatory-aligned methodologies
• How to effectively apply both ISO 10993 and USP <1663>/<1664> standards in a unified E&L strategy
• Regulatory considerations for navigating drug and device requirements in combination product development

Register for this webinar today to gain insights into developing a compliant, dual-purpose extractables and leachables program for drug-device combination products.

Speakers

Eric Hill, Chief Scientific Officer, Chemistry and Extractables & Leachables Labs, BA Sciences

Eric Hill joined Boston Analytical in 2014 as Director of the Extractables & Leachables laboratory. Prior to Boston Analytical, Eric spent 15 years at a contract analytical laboratory in various roles, including Analytical Scientist, Business Development Manager, Business Manager and President. Eric has an extensive background in polymer material characterization and contributes to industry groups and technical conferences in the E&L space. He holds a Bachelor’s degree in Chemistry from the University of Michigan, a Master’s degree in analytical chemistry from Central Michigan University and an MBA from the University of Michigan.

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Dr. Isaac Mohar, Principal Scientist/Toxicologist Gradient

Dr. Isaac Mohar is a Principal Toxicologist at Gradient where he has been a research consultant since 2014. As a Research Consultant, he supports clients in the pharmaceutical, medical device, agrochemical and consumer products industries. Prior to working at Gradient, Dr. Mohar conducted research in areas of drug-induced liver injury, reproductive genetics, immune tolerance and viral and parasitic immunity.

He received a doctorate in toxicology from University of Washington in 2008 and conducted postdoctoral training at Seattle Biomedical Research Institute and University of Washington. He is an author on 22 peer-reviewed publications and is an active member of the American College of Toxicology and Society of Toxicology.

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