The financial outlay has enabled part of the facility to be dedicated to the safe handling of cell and gene therapy (CGT) samples, including the installation of cryogenic storage, allowing biological materials such as cell therapies to be preserved in liquid nitrogen vapor at temperatures of around -180°C, said the CDMO.
The facility also has the ability to package, label and distribute cryogenic materials, ensuring the integrity of the therapies being prepared for clinical trials, and has been designed so that capacity can be rapidly expanded further to meet growing clinical supply needs, as well as future commercial demand, said Catalent.
“Establishing robust clinical supply chain services for cell and gene therapies is complex and challenging, and Catalent has undertaken an in-depth strategic review to evaluate how it can establish a safe, efficient and flexible approach to support this fast-growing area of the industry,” said Ricci Whitlow, president, Catalent clinical supply services.
She said the new set up in the 200,000 square-foot Philadelphia facility – the largest site in Catalent’s global clinical supply network – would also provide a template for the contract manufacturer to replicate at other facilities in that system, allowing incremental capacity expansion within the new infrastructure as demand grows.
Work at biologics drug substance facility finalized
Earlier this month, the CDMO also announced that it had completed the expansion of two new suites at its biologics drug substance development and manufacturing facility in Madison, Wisconsin, and had, as such, commenced work on customer programs.