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ACD/Labs Blog

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...

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...

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...

The Pfizer Structure Elucidation Group (SEG) spans two continents, supporting research and development in the UK and USA. In this presentation John talks about their structure elucidation workflow for assisted data processing and analysis, and centralized data management. John also presents some interesting case studies of puzzled they have solved.

Luminata—Cut your impurity data time investment from months into minutes

This article discusses how QbD requirements for risk assessment, process assessment, material assessment, documentation, and traceability can be addressed with informatics, using development of an impurity control strategy as an example.

Luminata™ offers a single system for organizing live, assembled analytical data for impurities within the context of a substance and the process by which it was made. PITTCON 2017, Chicago, IL (March 6, 2017)—ACD/Labs, an informatics company that develops and commercializes solutions in support of chemical and pharmaceutical R&D, today announced it will introduce Luminata™,...