Safety Evaluation on Extractables and Leachable
25th October 2022 | 10:00am EST / 7:00am PST / 3:00pm BST / 4:00pm CEST | Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Tino Otte, Head of Sales & Consulting at Intertek |WATCH FOR FREE
In order to ensure safety of patients, the toxicological risk assessment needs to thoroughly evaluate all potential risks which may be caused by any component present in a pharmaceutical drug product. Components to be considered include active pharmaceutical ingredient(s), excipients, impurities as well as extractables and leachables (E&L).
E&L do not contribute to efficacy of the pharmaceutical and therefore offer no benefit. But E&L may have negative impact on safety and/or quality of the drug product, and thereby can reduce the benefit/risk ratio. In consequence, the entry of E&L into the pharmaceutical product needs to be controlled and assessed. Adequate control of E&L requires an understanding of the materials used in production as well as the manufacturing process.
As the knowledge on the manufacturing process evolves during the development of a drug product or medical device, it is advised to include learning cycles into the development program to avoid existence of critical E&Ls. These learning cycles offer the opportunity to increase the knowledge on E&L associated with the product over its development time. Initially, chemical information should be collected on the materials used: First extraction studies will guide concerns, followed by simulation studies which are designed to mimic reality. At the end, the leachable study has to meet regulatory requirements and must cover real use conditions until end of product shelf-life, and these leachables need to be covered by a thorough toxicological risk assessment (TRA). Principles of the TRA will be explained in the webinar addressing also the assessment of compounds of specific concern such as nitrosamines.
Success factors for the preparation of a high quality E&L risk assessment are:
1) start early to avoid potential delays of the program and 2) ensure continuous collaboration of CMC and toxicology functions throughout the entire development process.
Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals
Dr. Clemens Günther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany.
He started his professional career in 1990 at Schering AG, Berlin-Germany. From 2000-2006 he became Head of Animal Pharmacokinetics where he also successfully supervised the generation of two doctoral theses.
From 2007 to 2013, Dr. Clemens Günther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later on as Bayer Dermatology. In this position, he was responsible for Nonclinical Safety for the marketed product portfolio of Bayer Dermatology as well as the global preclinical development strategy including human DMPK for development and life cycle management projects.
After integration of Intendis GmbH into Bayer AG in 2013, he became Director Nonclinical Safety Consumer Care and later on Senior Expert Nonclinical Safety within the Division of Bayer Pharmaceuticals.
Meanwhile, Dr. Clemens Günther gained over 30 years of experience in drug development from drug discovery to clinical phase III. His expertise includes nonclinical development and regulatory toxicology of small molecules, biologics, medical devices, and drug device combination products including assessment of impurities, extractables, and leachables. His achievements comprise the successful registration of several pharmaceutical products in various medical indications.
Tino Otte, Head of Sales & Consulting at Intertek
Dr. Tino Otte is the head of the sales and consulting department at Intertek in Switzerland and joined the company in 2016. Tino is an expert in extractables & leachables studies, impurity characterization and analytical method development with more than 13 years of experience in pharmaceutical analysis and polymer characterization. He is a chemist by training with a PhD in polymer chemistry from the Technical University of Darmstadt, where he graduated in 2010. Prior to joining Intertek, he worked in different management positions at UFAG-Laboratories, Hamilton Bonaduz AG and Postnova Analytics.
Sponsored by Intertek
Intertek PLC
Intertek is the industry leader with over 43,000 people in 1,000 locations in over 100 countries. Whether your business is local or global, we can ensure your products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world. We hold extensive global accreditations, recognitions, and agreements, and our knowledge of and expertise in overcoming regulatory, market, and supply chain hurdles is unrivaled. Intertek (Schweiz) AG provides a comprehensive range of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) compliant analytical services, including chemical trace analysis, reverse engineering, complex analyses, substance identification, method development, and a wide range of other applications in conjunction with consulting expertise and engineering support.
Intertek (Schweiz) AG
Intertek (Schweiz) AG, part of Intertek PLC and founded originally in 1884 as Ciba, is a GMP/GLP certified and FDA approved analytical service provider located in Reinach near Basel, Switzerland. Within the Intertek Group the Basel site is the centre of excellence for extractables & leachables studies having tested numerous packaging materials, container closure systems, production parts and medical devices during the past three decades.
Intertek Basel is also a pre-qualified laboratory of the WHO for anti-counterfeiting medicines and other analytical projects, recognized by international customers and the FDA as a trouble-shooter and method developer in case updated extractable data is required.