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"Accelerating Phase 1 Trials: Overcoming API Constraints and Tight Timelines with On-Demand Manufacturing"

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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.

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