Overcoming Nitrosamine Challenges - Innovative Strategies for Nitrosamine Prevention
WEBINAR
The presence of nitrites in excipients has become a major concern for regulatory agencies globally, as they can contribute to nitrosamine formation when interacting with susceptible amines during drug manufacturing and storage. This has led to recalls of affected pharmaceuticals. Our data suggests that nitrosamines in medications may be more common than previously thought. This webinar will cover current regulatory considerations, the role of nitrites, and necessary analytical controls, along with a case study on risk mitigation.
In this webinar, you will :
- Understand the role of nitrites in excipients and their contribution to nitrosamine formation
- Explore current regulatory frameworks and their implications for pharmaceutical manufacturing
- Review a case study illustrating successful risk mitigation in practice
- Discover effective risk mitigation strategies, including: pH modulation to reduce nitrosamine reactivity
- Learn about the application of scavengers to neutralize nitrites during production
Speakers
Thomas Kipping, Ph.D.
Merck
Associate Director, Head of 3D Printing & Solubility Enhancement
Thomas Kipping is a distinguished expert in the field of pharmaceutical technology and formulation development. Thomas is currently the Head of 3D Printing & Solubility Enhancement at Merck. With more than 15 years of experience spanning across various sectors within the pharmaceutical industry including drug product development and CDMO services, he has consistently demonstrated a strong commitment to advancing pharmaceutical sciences and enhancing drug development processes.
Dr. Ulrich Reichert, M.D.R.A.
Merck
Head of CDMO and Bioprocess Materials
Ulrich leads a global team supporting regulatory compliance for manufacturing active and biologic drug substances, including site registrations worldwide. With over 25 years of experience in regulatory and quality roles, he holds a PhD in Medicinal Chemistry and a Master in Drug Regulatory Affairs. Ulrich chairs the IPEC Europe Nitrosamine Task Force, participates in ICH and European Pharmacopoeia expert groups, and serves on the pharmacopoeia committee on medicinal chemistry at BfArM.
Joerg Schlingemann, Ph.D.
Merck
Director, Global Quality Control Principal Expert
Joerg Schlingemann is a director and principal expert for quality control systems within Merck's healthcare quality unit. He studied molecular biology in Uppsala and Heidelberg, where he completed a doctorate degree at the German Cancer Research Center in 2005. He has 14 years of experience in the pharmaceutical industry in various roles within quality control and quality assurance. Since late 2019, Joerg has been leading EMD Serono’s analytical activities for N-nitrosamines, based on which he has authored or co-authored several scientific publications dealing with analytical challenges, NDMA in metformin, nitrite in excipients, and the prevalence of NDSRIs. Joerg is an advocate of scientific collaboration, data sharing, and expressive visualization of data.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h
Language:English
Session 1:presented October 21, 2025