Catalent, a service provider for biopharma, cell, gene, and consumer health partners, today announced the launch of its Xpress Pharmaceutics service, designed to accelerate the development of oral drugs through Phase I clinical studies. By integrating formulation development, on-demand clinical manufacturing, regulatory support and clinical testing, the approach is aimed to reduce the cost and time taken to complete first-in-human trials.
The service allows the company to work alongside clinical research organisations and provide formulated trial material with the necessary stability data to be prepared for dosing patients at the clinical site, in line with adaptive study protocols. Catalent says its approach provides a faster alternative to the traditional clinical development model, and offers flexible dose and formulation adjustment during a clinical trial, guided by real-time data.
“Achieving early clinical success milestones as fast as possible is crucial in modern drug development, especially for emerging innovators, and this new service combines Catalent’s core expertise in drug formulation with manufacturing, analytics, and regulatory expertise, to design better drugs for use in adaptive trials,” said Jonathan Arnold, President, Oral and Specialty Delivery at Catalent.
“By focusing on the areas that are crucial for fast progression to, and through, Phase 1 trials, Xpress Pharmaceutics can potentially halve the time to complete studies.”
The service will be delivered at the company’s facilities in Nottingham, UK, and Beinheim, France, and supported by its global regulatory affairs team. To further support accelerated timelines, the company has a pre-qualified clinical research organisation partner, allowing transition from manufacturing into clinical testing.