Accelerating Phase 1 Trials Overcoming API Constraints and Tight Timelines with On-Demand Manufacturing
Summary: Early-phase trials are often delayed by rigid manufacturing models, fixed-dose formats, and limited API availability. In this case study, explore how a clinical-stage European biotech partnered with Catalent to complete Phase 1 trials in just 30 weeks using Catalent’s Xpress Pharmaceutics™ on-demand manufacturing platform. By integrating lipid-based formulation development, adaptive study design, and extemporaneous softgel production at the clinical site, Catalent enabled flexible dose escalation across a 75-fold range, while conserving API and minimizing manufacturing time. With MHRA approval and strong pharmacokinetic results, this agile approach outperformed conventional models, reduced costs by 38%, and helped the sponsor stay on track to clinical milestones.