Paper: 30 years of Extractables and Leachables (E&L) in Inhalation Products, a rapid(s) ride
Download PaperJason Creasey is a graduate Analytical Chemist. He setup in 2019 as an independent consultant providing advice on the topic of extractables and leachables (E&L), after working for GSK in the area of extractables and leachables since the mid 1990’s.
Over that time, he has seen demand in this area grow exponentially and Jason has held roles of increasing seniority in relation providing support to extractables and leachables. Before setting up Maven E&L Ltd - a specialist consultancy for all things E&L related, he was the director of a team of analytical chemists who were responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities. He has had the pleasure of commenting on OINDP PQRI guidelines on E&L for GSK and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.
Since setting up Maven E&L; he continues to present, discuss, and write about E&L. He is a scientific advisor to Extractable and Leachable Safety Information Exchange otherwise known as ELSIE and now is now publishing a regular E&L blog through LinkedIn and his Website (www.MavenEandL.com), mostly recently adding an E&L Forum for exchange of ideas. As well as supporting client projects, among recent E&L activity, he is working and commenting on risk- based approaches to E&L requirements that he hopes will form part of an ICH guidance in the not too distant future.