CDMO Catalent has invested to expand cryogenic capabilities at its clinical supply services facility in Philadelphia to meet cell and gene therapy demand.
The contract development manufacturing organization (CDMO) did not disclose any financial details of the investment.
However, a spokesperson for Catalent told BioProcess Insider “In addition to the equipment necessary to handle, package and label cryogenic materials, Catalent will add five cryogenic freezers with enough capacity for tens of thousands of vials at very low temperatures of around 180°C. The configuration also allows for additional freezers to be added.â€
Image/iStock: rodehi
According to the firm, the investment has resulted in part of the plant being dedicated to handling cell and gene therapy samples. This includes the installation of cryogenic storage, which enables cell therapies to be preserved in liquid nitrogen vapor at sub-freezing temperatures of approximately minus 180 degrees Celsius.
Catalent said the ongoing growth in the cell and gene therapy space drove the decision to expand.
In 2019, the US Food and Drug Administration (FDA) said that by 2025 it expects to be approving 10 to 20 cell and gene therapy products a year based on clinical success rates of products and the current pipeline.
“We expect this growth to be reflected in clinical trials activity, and this investment reflects increased demand for appropriate storage and handling of cell and gene therapies, and other biologic treatments that require specialized temperature control,†the spokesperson said.
The 200,000 square-foot Philadelphia facility has been designed for rapid expansion so that capacity and capability can be increased further to meet clinical supply needs and future commercial demand in its pipeline.
“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,†said Ricci Whitlow, president, Catalent Clinical Supply Services.