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ACD/Labs Blog

N-nitrosamines are a growing challenge in pharmaceutical development. This class of mutagenic impurity has been responsible for multiple rounds of recalls that have hit several major pharmaceutical companies. Watch Joseph DiMartino, the Luminata Solutions Manager present on “Using CMC Decision Support to Enhance Control Strategies” at the Scientific Update N-Nitrosamines Event. Topics include: Developing a data-driven...

This presentation provides an overview of the current state of research into N-nitrosamine impurities; what have we learned from systematic risk assessment, and what comes next.

How Chemical Manufacturing and Control (CMC) Software Helped a Major Pharmaceutical Company Improve Process Development and Regulatory Submissions Background: in 2019, a process development team at a top biopharmaceutical company. They felt data management was getting in the way of research and that too much time was spent preparing regulatory submissions. Challenge: the team wanted...

Biopharmaceuticals have boomed in recent years, with innovative researchers transforming complex biomolecules into effective therapeutics. Unfortunately, many of the common applications used by scientists do not meet the needs of this rapidly expanding R&D sector. Researchers need a chemically intelligent platform that understands the structure and properties of biochemical molecules. A vendor-neutral informatics environment will...