The business unit will work with developers of both biologics and traditional small molecules drugs, providing a range of manufacturing and regulatory consulting services.
Key offerings include early-phase injectables manufacture and the development of respiratory delivery formulations as well as cold chain distribution services for clinical trial materials.
Scott Houlton, president of the new segment, explained that the new unit will employ 900 people at sites in Germany, the US and the UK and said that this geographical spread will give the firm a market advantage.
Houlton told Outsourcing-pharma that while “There are many providers currently in the development services market, but few companies have the breadth of offering or the global reach of Catalent.”
He highlighted the unit’s ability handle smaller batch sizes, suggesting that it allows “customers to pursue the development of multiple compounds in a reduced period of time, reducing costs and increasing the chance of advancing the best compound.”
Regulatory experience
In a press release Catalent CEO John Chiminski suggested that the development and clinical services segment will provide “an integrated approach to solving the challenges our R&D customers face.”
Chiminski added that: “As we have been involved in more than a third of NDAs and BLAs approved by the FDA in the last seven years, we know what it takes to bring a customer’s drug or biologic to market.”
