Catalent fills gap in the market with new development offering, Xpress Pharmaceutics

Xpress Pharmaceutics will facilitate adaptive clinical trials and reduce the time taken to complete FIH studies

The company claims its more advanced development offering integrates formulation development with clinical manufacturing, regulatory support and clinical testing, to help achieve flexible and efficient First-in-Human (FIH) and proof of concept studies, and expedite development.

At the heart of this program is the ability to adjust both formulation and dose based on real-time clinical data, using on-demand manufacturing approaches and adaptive clinical design protocols.

The new launch is reported to be able to take a product from formulation development, through analytical development, clinical trial manufacturing and release, to dosing within 4 to 6 months, in effect, achieving complete FIH studies 5 to 6 months sooner than traditional CMC models, which currently takes approximately 9 to 12 months.

According to the company, Xpress Pharmaceutics will also offer scalable formulations for rapid dose adjustments at the clinical site, as well as "significant" API, time and cost savings.

Furthermore, the program's integrated approach will also support customers’ regulatory filing strategies.