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

In an effort to respond to clinical studies' requirement for adaptive dosing of oral drugs, Catalent has launched Xpress Pharmaceutics, a program which provides flexibility in dose selection.

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.

ABOUT CATALENT PHARMA SOLUTIONS

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has the proven expertise, superior technologies and flexible solutions at the right scale to help ensure successful product development, launch, tech transfer and global reliable supply. Our team of nearly 13,000, including approximately 2,400 scientists at over 35 sites, develops more than 700 projects and helps launch over 200 products every year. We produce +72 billion doses of +7,000 products for more than 1,000 customers – or 1 in 20 doses taken by patients globally. We partner with 87 of the top 100 global pharmaceutical marketers, to 24 of 25 biological marketers, to 21 of 25 leading consumer health marketers, to thousands of small innovators globally. Our passion is to help unlock the full potential of your product.