Optimising API and Drug Product Development Through an Integrated CMC Strategy

Stephen Hughes, Associate Director of Chemistry Late Phase Small Molecule Development, highlights how an integrated CMC strategy can dramatically streamline the journey from early API development through to commercial readiness. The case study shows how rapid process development, smart form selection, and close collaboration between drug substance and drug product teams enabled fast progression, even when challenges such as agglomeration and nitrosamine risk emerged.

By unifying API and DP activities under one quality system and one project team, the programme avoided the delays typical of multi‑CMO handovers. This integrated model removed the need for “release testing at multiple sites and shipping between facilities,” ultimately accelerating delivery and strengthening supply chain control.

To explore the full development story, including timelines, technical decisions, and the benefits of an integrated approach – access the complete resource.