Managing the development
of the drug substance route
of synthesis and manufacturing
process for an innovative molecule
in the preclinical phase

Summary

The project involved the development of a manufacturing method for a drug substance that is a candidate for an innovative drug product. It included coordinating work with contract development and manufacturing organisations and ensuring quality standards were consistent with applicable U.S. FDA and EMA guidelines. The work’s first stage was developing a synthesis route on a laboratory scale, followed by initial process optimisation.

In the next step, the production scale was increased to pilot, and an initial control strategy for process parameters and product attributes was proposed. A batch of the drug substance was also manufactured to conduct the preclinical phase.