Mass Transport Modelling in support of leachable risk management
17th January 2023 | 10:00am EST / 7:00am PST / 3:00pm GMT / 4:00pm CET | Thomas Egert, Research Scientist Pharmaceutical Contact Materials at Boehringer Ingelheim Pharma GmbH and and Jason Creasey, Managing Director at Maven E&L Ltd |WATCH FOR FREE
Leachable risk management continues to be of regulatory interest. However we continue to rely on experimental extractable studies as predictors of leachable risk. These are complex to design and implement, and do not always offer the answer to what is the leachable risk for a drug product or medical device. We hope to show that mass transport modelling provide an alternative or a complementary element to testing the leachable risk. There are relatively simple mathematical models which can be developed which might provide an estimate of maximum leaching in a system. These can estimate factors such as solubility, partitioning and diffusion if successfully constructed and in combination these can estimate leaching. There are several ways which these might be modelled and this presentation will discuss each one. The presentation will illustrate where modelling might replace or support current approaches which rely upon experimental study. Results from modelling is complementary to risk appraisal, as predictive modelling gives quick insight into effects of storage time, temperature and other kinetics of leaching. This could be used to screening different materials and predict their leaching characteristics perhaps more effectively and efficiently than current extractable test protocols leading to better leachables studies to confirm these models.
Presented by Thomas Egert, Research Scientist Pharmaceutical Contact Materials at Boehringer Ingelheim Pharma GmbH
Thomas is a research scientist at Boehringer Ingelheim, Germany. Dedicated to analytical chemistry for 25+ years, his current role includes responsibility for materials selection and E&L qualification as well as analytical troubleshooting in the context of materials primary contact applications (packaging, manufacturing process-equipment and medical devices). Thomas is an active member of the Extractables and Leachables Safety Information Exchange Consortium (ELSIE) and the PQRI Parenteral and Ophthalmic Drug Product (PODP) – E&L Working Group. Contributing to several industry seminars in the field of pharmaceutical packaging, his special interest is devoted to research of predictive physicochemical concepts describing mass transport between polymers and contacting pharmaceuticals. Along with experimental procedures, predictive modeling presents a viable route to generate patient exposure estimates for use in a leachables risk framework. Prior to joining Boehringer Ingelheim, he held various positions in the field of organic trace analysis at an analytical service provider. Thomas holds a diploma in chemical engineering and a master’s degree in bio- and pharmaceutical analysis.
Followed by Jason Creasey, Managing Director at Maven E&L Ltd
Jason Creasey is a graduate Analytical Chemist. He set up 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 1990s. Over that time, he has seen demand in this area grow exponentially and Jason has held roles of increasing seniority in relation to 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), most 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.