Small Molecule Drug Substance Development: Part 1 - How Do You Design A Safe And Scalable Synthetic Route For Your Drug Substance?

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

At the point of candidate selection, a chosen drug substance will typically have been prepared in only small quantities (up to a few grams) to support initial medicinal chemistry activities. The synthetic route used for this initial supply is rarely suitable for producing larger quantities of material for downstream development and will typically need to be modified, or sometimes redesigned entirely, to produce enough material for first-in-human (FIH) clinical trials.

At Quotient Sciences, we have a state-of-the-art facility in Alnwick, UK, where we work with our customers to address these challenges. An experienced team of process chemists work alongside colleagues in analytical chemistry and material science to develop safe, scalable, and economical synthetic routes to achieve a suitable drug substance.