Small Molecule Drug Substance Development: Part 2 - How Do You Streamline Manufacturing Of Your Drug Substance?

By Richard Castledine, Head of PR&D, Drug Substance, and Paul Quigley, Principal Research Fellow, Drug Substance, Quotient Sciences

In the previous blog post in this three-part series, we discussed how to design a safe and scalable synthetic route for your drug substance – Part 1: How Do You Design A Safe And Scalable Synthetic Route For Your Drug Substance?

The next challenge is to develop a safe and efficient manufacturing process that is capable of consistently producing your drug substance at the intended quality at a larger scale. When developing a drug substance manufacturing process, considering the impurities that are produced is as important as the drug substance itself. You need to identify, quantitate, and ultimately control the impurities generated in the manufacturing process, as small differences in impurities can have a significant impact on the toxicological profile of the compound.