Catalent Adds Cryogenic Capabilities at Philadelphia Clinical Supply Services Facility to Meet Growing Demand for Cell and Gene Therapy Development 15th April 2021
Catalent, the leading global provider of advanced delivery technologies, development, manufacturing, and clinical supply solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it has made an investment to expand capabilities at its clinical supply services facility in Philadelphia to support sponsors developing cell and gene therapies.
The investment has enabled part of the facility to be dedicated to the safe handling of cell and gene therapy 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 minus 180 degrees Celsius. 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.
“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,” commented Ricci Whitlow, President, Catalent Clinical Supply Services. She added, “The solution we have implemented at Philadelphia not only meets current needs, but also provides a template for us to easily replicate at other facilities in our global network, allowing incremental capacity expansion within the new infrastructure as demand grows.”
The 200,000 square-foot Philadelphia facility is the largest site in Catalent’s global clinical supply network, and the company’s North American Center of Excellence for clinical supply packaging. It includes an on-site pharmacy to support FlexDirect™ direct-to-patient service for clinical trials, as well as offering customers access to Catalent’s FastChain® demand-led supply services, primary and secondary packaging capabilities, a range of temperature options for storage and distribution, and clinical returns and destruction services.
With sites in the U.S., U.K., Germany, Singapore, Japan and China, and an extended network of over 50 depots, Catalent’s clinical supply services can handle a broad range of international compliance and distribution requirements to support global clinical trials.