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ACD/Labs Blog

Sherry Myles
Development of pharmaceutical drugs encompasses the use of multiple data sources such as chemical structures, analytical data, meta data, and process parameters. The data types are often siloed in electronic lab notebooks (ELN), laboratory information management systems (LIMS), chromatography data systems (CDS), in-house databases, etc. Development teams often use Excel spreadsheets to summarize all this...

Joel Michalski
Quality-by-Design (QbD) is a modern approach to impurity control supported by pharmaceutical industry regulators. Pharmaceutical development groups need support from their informatics infrastructure to implement this strategy. Effective leveraging of QbD in risk mitigation requires an informatics platform that does not rely on data abstraction, simplifies data assembly, and reduces the need for human data...

Sherry Myles
Novartis employs a variety of ACD/Labs software in support of structure elucidation and structure verification in pharmaceutical development and post-commercialization. Here they present: Their workflow for structure identification and elucidation for impurities and degradants Time-savings from automated structure verification—a system supporting research chemists for several years The importance of integrated, centralized data management in impurity...

Sherry Myles
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 Joe 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...

Joel Michalski
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.