Catalent reported that it increased cold chain packaging capabilities at its Philadelphia facility to support the growing increased demand for the distribution of biologic drugs, and advanced cell and gene therapies. Work has been undertaken at the facility to expand the packaging area by around 20,000 ft2 and includes the addition of seven new temperature-controlled processing suites, which can operate at either refrigerated or frozen conditions to precisely match the needs of the drugs being handled. Further ambient space has also been added for packaging operations and materials storage.
The new suites include full serialization capabilities, specifically designed for small-scale batches of commercial products, according to the company. Validation of the equipment is expected to be completed by the end of Q1 2022.
“Advanced therapeutics require increasingly complex handling requirements, and the investment we have made in Philadelphia allows Catalent to operate efficient packaging processes and operations, bridging the gap between clinical scale and niche commercial volumes,” said Ann McMahon, general manager of commercial & integrated development operations at Catalent Clinical Supply Services. “The specifically designed packaging areas not only provide optimal commercial opportunities for drug developers, but also the safest working conditions for employees in terms of air exchange rates, carbon dioxide monitoring, and ultraviolet air sanitization.”
The 200,000 ft2 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 services for clinical trials, as well as 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.