Case Study

A Quick, Cost-Effective Process For Large-Scale Compound Synthesis For A Leading Pharma Company

Source: Syngene International Ltd.
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The client is a leading global pharma company that uses innovative science and digital technologies to create transformative therapies, with products reaching nearly one billion people worldwide. The client was seeking a suitable route modification process that could demonstrate the scalability and safety of the final drug product at minimum cost.

Syngene’s chemical development team received a proposal from the client to develop a quick, scalable, safe, and cost-effective process for taking their compound from lab-scale to cGMP-scale. The compound, developed by the client’s offshore Medicinal Chemistry team, was based on seven linear synthetic steps with a low average yield of around 7%. The process for drug development also comprised five chromatographic purification steps, as a result of using toxic and hazardous chemicals during route development.

This case study explains how Syngene minimized costs while ensuring quick turn-around time when scaling a client’s compound from lab-scale to cGMP-scale. Syngene not only delivered, as per timelines, but also increased yield by 25% and reduced the overall drug product cost by 65%.

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