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Consolidating and Managing Data for Drug Development within a Pharmaceutical Laboratory

Published online at Organic Process Research & Development.

by Arvin Moser, Alexander E. Waked, and Joseph DiMartino

This article compares the use of Luminata and Microsoft Excel for consolidating and managing all the analytical data in pharmaceutical drug development.

The Excel document becomes the ultimate repository of information extracted from multiple sources such as the electronic lab notebook, the laboratory information management system, the chromatography data system, in-house databases, and external data. The major needs of a pharmaceutical company are tracking the stages of multiple reactions, calculating the impurity carryover across the stages, and performing structure dereplication for an unknown impurity. As there is no standardized software available to link the different needs throughout the life cycle of process development, there is a demand for mapping tools to consolidate the route for an API synthesis and link it with analytical data while reducing transcription errors and maintaining an audit trail.
Moser, A., Waked, A.E, DiMartino, J. (2021). Consolidating and Managing Data for Drug Development within a Pharmaceutical Laboratory. Org. Process Res. Dev. Published online Sept. 14, 2021. https://doi.org/10.1021/acs.oprd.1c00082