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March 1-5, 2020
McCormick Place, Chicago, IL, USA

Room: W175A

A Strategy to Control Impurities using a Batch Genealogy Mapping Tool
Matthew J. Binnington, Joe DiMartino

Successful completion of API process development is a tremendously challenging task, made even more difficult by the amount of analytical data that is collected. The numerical and non-numerical information compiled may be scattered amongst the project team: within email, Analytical ELN, and Chemistry ELN systems. While scientists have developed practices to consolidate analytical data and construct corresponding process maps (i.e., route schema, batch family tree, formulations map, etc.), this remains a tedious manual process where simple questions often become difficult to answer.

In this presentation, we will provide an overview of a CMC development decision support application built specifically to address these challenges. Luminata® offers the ability to construct process maps, allowing for visualization of the impurities at each stage of the route, and visual comparison of molecular composition across unit operations. This process map is quite flexible and can represent the synthetic route of the API or a representation of the batch family tree, visualizing the relationships between batches. This enables rapid assessment and decision-making around the effectiveness and efficiency of impurity control measures. Within the batch family tree, connection of live analytical data facilitates easy visual confirmation of the veracity of numerical/textual interpretations, and access to processed results without the need to utilize multiple software applications.

Through the identification of the batch related impurities, from well-managed and assembled analytical data, Luminata allows for rapid visual comparisons of analytical data on a batch-to-batch, process-to-process basis and risk assessment pertaining to impurity onset, fate, and purge. By storing all batch analytical information that would otherwise be locked into chromatography systems and various ELNs, the software empowers process development teams to make the right decision the first time around.