Genotoxic Impurities: Nitrosamines LC-MS TOF screening analysis with automated sample preparation

Topics in this Webinar:

• A brief history of the Nitrosamines problematic in context with the genotoxic impurities of Nitrosamines
• The screening of potential undetected nitrosamines using the Waters BioAccord Smart MS system
• How to overcome the challenges in sample preparation for the analysis of highly genotoxic impurities like Nitrosamines
• How to achieve highly robust and reproducible results by eliminating the manual handling through automation using the Andrew+ robot in connection with the OneLab software.

Topic 1: Automating Sample Preparation to Mitigate Risks in Nitrosamine Impurity Analyses

LC-MS analytical method development requires flexible and reproducible sample preparation for accurate and robust analyte quantification. This presentation will highlight automated calibration curve generation using the Andrew+ Pipetting Robot, with cloud-native OneLab Software, for accurate and reproducible LC-MS quantification of nitrosamine impurities.

Topic 2: UPLC-TOF Platform for N-Nitrosamine Investigation in Pharmaceuticals

Since June 2018, thousands of batches of pharmaceuticals have had to be recalled due to the unexpected presence of nitrosamines worldwide. EMA and FDA guidelines now indicate small aliphatic and aromatic nitrosamines that are currently being screened for, but there are already new ones on the horizon. In this webinar, we will present the latest LC-TOF strategies using the Waters BioAccord system. These can be used to screen for potential undetected nitrosamines early in the drug development and risk assessment process to ensure patient safety and drug supply.

Presenter: Nadim Mira (Product Marketing Analyst II, Andrew Alliance France SASU)

Nadim MIRA graduated in 2013 from the University of Orleans, France with a master’s degree in Biochemistry, Molecular Biology, and Biotechnology. He then joined the Department of Fundamental Microbiology at the University of Lausanne, Switzerland as a Ph.D. student in an SNF-funded research project. After 2 years, he left the Ph.D. program to pursue a corporate career. In 2018, he completed a second master’s degree in Sales and Marketing in the life science industry at the University of Grenoble Alpes, France before joining Andrew Alliance as an Inside Sales Representative. In 2019, he moved to a new role in the marketing team, serving as a Product Marketing Analyst responsible for protocol publication and labware management in the OneLab cloud-native software as well as method development and automation feasibility assessment.

Presenter: Sebastian Schmidtsdorff (Deputy Head of Quality Unit & Project Manager, Chromicent GmbH)

Sebastian Schmidtsdorff graduated in 2015 at the Free University of Berlin, Germany as a pharmacist. He then joined a research fellowship in the Department of Pharmaceutical Analysis and Chemistry at the Faculty of Pharmacy, Free University of Berlin, Germany. In 2017, he moved to Chromicent GmbH in Berlin-Adlershof as a project leader and external doctoral student with the main focus in analytical method development and the use of novel chromatographic analytical techniques. Sebastian Schmidtsdorff is also lecturer in pharmacopoeial analysis for pharmacy students and deputy head of the Quality Unit at Chromicent GmbH.

Presenter: Claudio Pasqual (Specialist Biopharmaceutical Market, Switzerland, Waters Corporation)

Claudio is member of the Central European Strategic Market Team. He obtained is Advanced Federal Diploma of Professional Education and Training as Senior Scientific Laboratory Technician in 2003. Before joining Waters he was Head of Laboratory of the R&D Lab at Tillotts Pharma AG.

Claudio started at Waters in 2003 as field sales specialist for the consumables group. Since 2019 he takes care of the complete solutions for the biopharmaceutical market in Switzerland.