Small Molecule Drug Substance Development: Part 3 - Once Your Drug Substance Has Been Manufactured, How Do You Successfully Bridge Into Drug Product Development?

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 streamline manufacturing of your drug substance – Part 2: How Do You Streamline Manufacturing Of Your Drug Substance?

The next challenge is formulating your drug substance (active pharmaceutical ingredient [API]) with other inactive ingredients (excipients) into a finished dosage form (drug product) for clinical trials.

The interface between drug substance and drug product is a key part of the drug development pathway. Drug substance and drug product development are often carried out by different organizations, which can be inefficient and costly, leading to poor knowledge and material transfer, and delivery delays. The complexity of today’s drug molecules and target product profiles (TPPs), and the timeline pressures that drug developers are faced with, exacerbates these challenges.