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, 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.
For further information on Catalent’s Clinical Supply Services business visit https://www.clinical.catalent.com.
?ABOUT CATALENT CLINICAL SUPPLY SERVICES
Catalent is a global leader in clinical supply services, with comprehensive and flexible solutions for small molecules, biologics, and cell and gene therapies and integrated solutions to accelerate speed to clinic. Catalent offers a full range services including clinical supply management, comprehensive packaging solutions, comparator sourcing, cold chain storage and global distribution and specialized supply chain services including direct-to-patient and demand-led supply. With nine GMP clinical packaging facilities and over 50 strategically located depots on six continents combined with more than 25 years’ experience across thousands of studies in more than 80 countries, Catalent has the comprehensive services, global scale and expertise necessary to reliably supply clinical trials of all sizes and complexity anywhere in the world.
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 15,000 people, including around 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey.