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.
That facility provides development, production, and analytical services for new biological entities and biosimilars. The expansion has increased the number of manufacturing suites at the site to five, more than doubling its overall CGMP-scale capacity.
Catalent first reported the plan to add two new mammalian cell culture suites at the Madison site in January 2019.
Each new suite includes a 2×2,000-liter single-use bioreactor system capable of processing batches of 2,000 liters or 4,000 liters for CGMP clinical and commercial manufacturing.
Long-term deal for dedicated vial filling of Moderna’s vaccine
In terms of Catalent’s work on vaccines, April 3 saw it confirm the expansion of its strategic collaboration with Moderna.
The CDMO said then that it would dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other investigational programs in the biotech’s pipeline at its biologics facility in Indiana.
In June 2020, the parties announced that Catalent would provide aseptic vial filling and packaging from that Bloomington located site, including additional staffing required for 24/7 manufacturing to support production of an initial 100 million doses of Moderna’s vaccine. On March 29, the biotech reported that milestone had been achieved.
As part of this expanded agreement, Catalent will now dedicate a new high-speed filling line at the site for Moderna’s use, all the way through to June 2023. The line can be used to manufacture the COVID-19 vaccine and other Moderna products.
The CDMO will also provide inspection, labeling, cartoning, and final packaging for those products.