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
