Critical impurities and limits: A fireside chat on genotoxic impurities

Overview

Genotoxic impurities are compounds that can cause damage to DNA, potentially leading to cancer and other health risks. As a pharmaceutical company or contract manufacturer (CDMO), it is crucial to identify and quantify these impurities to ensure that active pharmaceutical ingredients (APIs), excipients and formulations are safe and comply with regulatory requirements. Join us for an insightful fireside chat on genotoxic impurities and how they affect the safety of medicines.

In this discussion, our industry experts draw on their experience in toxicology, analytics, regulatory affairs and business development to address the latest trends and challenges in genotoxic impurity testing. This session is highly relevant to anyone working in API clinical stage development, research, process development or outsourcing at pharmaceutical and generic drug makers. Learn about the interdisciplinary approach needed to navigate the complex landscape of genotoxic impurities and make medicines safer for patients.

Discussions in this session will focus on:

Dealing with the discovery of unexpected impurities such as nitrosamines
How to set limits for critical impurities
Strategies for tracking impurities analytically

Experts featuring this session

Dr. Daniel Bertow
Hazard & Risk Management - Product Stewardship
Evonik Health Care
Vita

Daniel has more than 15 years’ professional experience in the field of human health risk assessment. He joined Evonik in 2009 and has contributed his toxicological expertise to various regulatory fields.

His main focus has been on deriving OELs (occupational exposure limits) and PDEs/ADEs (permitted/acceptable daily exposures). In addition, he has experience in the preparation of impurity and contamination assessments.

Daniel holds a Ph.D. in food toxicology and is a registered toxicologist (DABT).

Dr. Michael Nonnenmacher
Director Global Business Development Differentiating Technologies
Evonik Health Care
Vita

Michael Nonnenmacher is currently the Director Differentiating Technologies within the Product Line Drug Substance at Evonik Health Care.

He has 15 years of experience in CMO business and fine chemical industry and a long track record in Pharmaceutical Process Development.

Michael holds a PhD in organic synthesis from the University of Heidelberg (Germany) and completed a PhD research fellowship at Texas A&M University, College Station, TX.

Dr. Jürgen Volz
Head of Laboratory Mass Spectrometry Hanau, RD&I Analytics
Evonik Health Care
Vita

Jürgen has more than 25 years of professional experience in the fields of chromatography and mass spectrometry.

He joined Evonik in 2013 and is heading the laboratory for mass spectrometry in Hanau. Main focus is the elucidation of unknown impurities in different products by high resolution mass spectrometry as well as quantitative analysis of potential toxic trace impurities by triple stage quadrupole mass spectrometry. The latter can be done in compliance with GMP for release analysis in his laboratory.

Jürgen holds a Ph.D. in chemistry.

Elizabeth White
Global Senior Expert Regulatory Affairs
Evonik Health Care
Vita

Elizabeth has nine years’ experience in the field of regulatory affairs, previous experience in direct production support in quality assurance and technical services.

The area of genotoxic impurities (ICH M7) and the subset nitrosamine impurities is a key area of the CMC preparation. Evonik regulatory personnel have prepared drug substance submission in multiple markets, including the US and Europe, with successful approvals.

As a member of the regulatory team, Elizabeth prepares the CMC filings. Elizabeth holds a MS-ChE from Lehigh University in the US.