Case Study: Integrated Control of Genotoxic Impurities in API Development

A European biotech developing a novel molecular entity (NME) partnered with Arcinova to establish a robust, regulatory-ready API development strategy.

This case study demonstrates how Arcinova's integrated chemistry, analytical and regulatory expertise enabled early identification and control of GTI risks, simplified a complex synthetic route from six steps to three, and developed a comprehensive impurity control strategy suitable for Phase II development.

Download the case study to discover how integrated CMC, analytical and regulatory expertise can help identify GTI risks earlier, prevent rework and support successful regulatory submissions.