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.
Ulrich Reichert, Ph.D.
Merck
Global Regulatory Management
Ulrich Reichert heads the regulatory management - pharma and food materials organization of the life science business of Merck KGaA, Darmstadt, Germany. He is responsible for registration of APIs and excipients with health authorities (master files), and he acts as the principal contact for site registration with the GMP-supervisory authority. Ulrich is a pharmacist by training, holds a Ph.D. and an M.S. in drug regulatory affairs, and has more than 20 years of experience in quality and regulatory requirements for raw and starting materials in the pharmaceutical industry.
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
期间:1h
语言:English
场次 1:Tue, October 21, 2025 2:00 PM CEST
如要继续阅读，请登录或创建帐户。
暂无帐户？