Risk Assessment of Extractables and Leachables in Different Phases of Development.

22nd April 2021 | 10:00am EST | Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals |BOOK FREE SEAT FOR THIS WEBINAR

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.

Success factors for the preparation of a high quality E&L risk assessment are:

1) start early to avoid potential delays of the program

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 successful registration of several pharmaceutical products in various medical indications.

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