Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced the launch of its new Xpress Pharmaceutics™ service, designed to accelerate the development of oral drugs through Phase 1 clinical studies. By integrating formulation development, on-demand clinical manufacturing, regulatory support and clinical testing, the approach can reduce both the cost and time taken to complete first-in-human trials.
Xpress Pharmaceutics allows Catalent to work alongside innovator and clinical research organizations, and provide formulated clinical trial material with the necessary stability data that can be prepared for dosing patients at the clinical site, in line with adaptive study protocols. This approach provides a faster alternative to the traditional clinical development model, and offers the advantage of flexible dose and/or formulation composition adjustment during a clinical trial, guided by real-time clinical 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 by formulation development experts at Catalent’s facilities in Nottingham, U.K., and Beinheim, France, and supported by the company’s global Regulatory Affairs team. To further support accelerated timelines, Catalent has a pre-qualified clinical research organization partner, allowing seamless transition from manufacturing into clinical testing.