Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them?

03rd February 2020 | 10.00 am EST | Jason Creasey, Analytical Chemist at GSK and Karen Pieters, Ir. Team Leader Extractables and Leachables at Nelson Labs Europe |BOOK FREE SEAT

The term “Simulated leachable studies” is open to interpretation. I hope to provide a definition of this term and in doing so suggest when they can and should be used. The general aim of such studies is to provide an accurate qualitative and quantitative description of the substances which might be present as leachables in a pharmaceutical drug product (DP) derived from container closure system (and sometimes its manufacturing process) when the drug product is stored up to and including its shelf-life. Simulated studies provide an alternative to analysis of leachables directly in the drug product. A simulated study aims to avoid some of the downfalls of leachable analysis such as; inaccurate analysis of leachables due to interference from drug product and/or formulation elements, availability of stored DP samples, reaching required limits of detection in the DP and time / resource constraints associated with complex method development using DP.
Simulated leachable studies must be able to accurately simulate the expected leachables in a DP and should be carefully crafted to achieve this. The system used for extraction must have similar propensity to leach from materials under study a drug product and care must be taken not to use system which either leach too much (potentially masking other substance) or too little.

Presented by Jason Creasey, Analytical Chemist at GSK

Jason Creasey is a graduate Analytical Chemist. He has worked for GSK since 1990, working full-time in the area of extractables and leachables since the mid 1990’s. Over that time period he has seen demand in this area grow exponentially. During that time Jason has held roles of increasing seniority relating to the support that GSK has given to extractables and leachables (E&L). He is currently the director of a team of analytical chemists who are responsible for GSK’s support for E&L activities across a wide range of product types and modalities across large and small molecules including inhalation, parenteral and topical use. He has had the pleasure of commenting on PQRI guidelines on E&L for GSK and the E&L section in EMEA guidelines on inhalation and nasal products and co-author of a chapter within book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.
Jason is a member of several external groups concerned with the development of best practice guides for extractable and leachables issues these include; the IPAC-RS material working group, BPOG and Extractable and Leachable Safety Information Exchange otherwise known as ELSIE. Currently working and commenting on risk- based approaches which he hopes will form part of an ICH guidance in the future.

And Karen Pieters, Ir. Team Leader Extractables and Leachables at Nelson Labs Europe

Karen Pieters graduated as a bio-engineer in chemistry in 2006.  After graduation, she worked for three years as a Quality Document Expert at Merck, Sharp & Dohme (MSD), gaining experience in the regulatory and analytical challenges of pharmaceutical industry. In 2010, Karen started working at Toxikon Europe, now known as Nelson Labs Europe, as a Study Director for extractables and leachables studies with a special focus on single-use materials used in the manufacturing of biological drug products. She is now responsible for a team of Study Directors specialized in extractables and leachables studies on Large Volume Parenterals, Ophthalmics and Disposable systems used in manufacturing. She has presented on the set-up and challenges for these applications at several international conferences.

Sponsored by Nelson Labs Europe

Nelson Labs, A Sotera Health company, is the leading, global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex problems. We have over 700 scientists, technicians, and service specialists who diligently perform more than 700 rigorous tests in 13 global laboratory locations.
Based in Belgium, Nelson Labs Europe specializes in providing premium Extractables & Leachables testing services to the pharmaceutical and medical device industries. We also support pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify container/closure applications and pharmaceutical production equipment from an Extractables & Leachables perspective.

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