The expanded capabilities will allow the company to meet increased demand for the distribution of biologic drugs, and advanced cell and gene therapies
The expanded cold chain capabilities support the distribution of biologic drugs, and advanced cell and gene therapies. (Credit: MasterTux from Pixabay)
Catalent, a provider of clinical supply services, has expanded its cold chain packaging capabilities at its Philadelphia facility in the US.
The expanded capabilities will help the company to meet increased demand for the distribution of biologic drugs, and advanced cell and gene therapies.
Catalent has expanded the facility with the addition of up to 20,000ft2 space, which houses seven new temperature-controlled processing suites.
The new suites consist of full serialisation capabilities that are essentially designed for small-scale batches of commercial products.
To precisely meet the requirements of drugs being handled, the suites can be operated at either refrigerated or frozen conditions.
Catalent is planning to complete the validation of the equipment by the end of first quarter this year.
The company has also added further ambient space for packaging operations and materials storage.
Catalent clinical supply services commercial and integrated development operations general manager Ann McMahon said: “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.
“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 sanitisation.”
The 200,000ft2 Philadelphia facility is said to be the largest site in Catalent’s global clinical supply network, as well as the firm’s North American Centre of Excellence for clinical supply packaging.
The facility consists of an on-site pharmacy to deliver FlexDirect direct-to-patient services for clinical trials.
It also offers access to Catalent’s FastChain demand-led supply services, primary and secondary packaging capabilities, in addition to a range of temperature options for storage and distribution, and clinical returns and destruction services.