Case Study: From Isotope Labelling Strategy to Successful ADME Study Delivery

Developing a radiolabelled API that supports ADME studies requires a strategy that balances scientific, operational and regulatory considerations.

In this case study, discover how Arcinova transformed an existing cGMP manufacturing process into a robust isotope-labelled route, achieving 99.8% radiochemical purity, maintaining process alignment and establishing key parameters to support future GMP manufacture. The result was a reliable, regulatory-ready solution that accelerated programme timelines and enabled successful study delivery.

Download the case study to learn how our radiochemistry expertise helped de-risk development and support progression towards clinical studies.