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Organic Process Research & Development (OPRD)

June 17-19, 2019
, Toronto, ON, Canada

Presentation Schedule

MONDAY, JUN. 17TH, 12:00 PM

A Technology-driven Approach to More Effective Impurity Lifecycle Management
Andrew Anderson, Sanjivanjit K. Bhal, and Joe DiMartino

Regulatory authorities expect pharmaceutical development to demonstrate process and product understanding according to Quality by Design (QbD) principles. The overarching goal of this is to ensure that medicines are safe and efficacious. To achieve these goals, control strategies must be developed which comprehensively assess, classify, and report process route development. Ultimately controlling process inputs and materials, their attributes, the design spaces around unit operations, methods, variability, and final product specifications. Impurity mapping lies as the foundation of this. While scientist have developed practices to gather this information, it remains a tedious manual process.

In this presentation we will provide an overview of a new software application developed specifically to address these challenges. LuminataTM 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 enables rapid assessment and decision-making around the effectiveness and efficiency of impurity control measures. The software also stores the context of the experiment and expert interpretations, and offers the capability to perform both batch and risk assessments.

Beyond incorporating good manufacturing practice (GMP) into drug substance production, Luminata may be utilized to evaluate in-process samples, filtrates, or any other desired process stream to assist with synthesis optimization. Within a record, process chemists can examine the impacts of different conditions (such as temperature or solvents) on process optimization; for example, whether altering a given condition will generate more impurities at each stage.