Catalent has announced that it is investing $10 million in isolator capabilities at its sites in Malvern, Pennsylvania and Dartford, UK, to expand its micronisation capabilities for highly potent drug compounds.
The investment will allow flexible jet milling operations to be carried out at both sites under containment to a working occupational exposure limit (OEL) of 0.05 micrograms per cubic metre, enabling micronisation of potent and highly potent compounds, at less than 10 and less than 1 microgram per cubic metre respectively.
Additionally, the capability to operate under an inert nitrogen environment offers enhanced manufacturing safety, eliminates the risk of dust explosion for compounds with low minimum ignition energy (MIE) values, and enables the processing of humidity, light and oxygen-sensitive materials. Work is underway at both facilities, with installation and validation activities likely to be completed by mid-2021.
At Dartford, the isolator will encompass a K-Tron gravimetric feeder with KT35 hopper and feed screws, suitable for 8-inch and 12-inch jet mills. The DEC Group designed system will be fully automated and allow product and waste to be collected within a safe, controlled environment. At the Malvern facility, the nine-chamber isolator will be housed within a new extension at the site, and will be one of the biggest isolators installed in the US.
The multi-chamber design, undertaken by FPS Architects & Engineers Limited, offers superior ergonomics and is optimised to significantly reduce cleaning and maintenance time.
"Catalent offers multiple tools and technologies to drug innovators to improve the characteristics and efficacy of new molecules, and micronisation is an important engineering step for many materials to help improve the solubility of oral drugs and optimize inhaled therapies," said James Walter, VP of Operations for Oral and Specialty Delivery at Catalent. "This investment allows us to ensure that access to this technology is not limited, as we see the development of highly potent molecules becoming more prevalent in the small molecule R&D pipeline against a number of disease targets."
The Dartford and Malvern sites offer expertise and experience in particle size reduction capabilities including micronisation, jet milling, mechanical milling, cryogenic milling and associated analytical services, and work alongside Catalent's network of commercial-scale facilities.
The company recently announced the launch of its OneXpress solution to integrate and accelerate a programme's transition from early-phase development to commercial-ready manufacturing by leveraging its phase-appropriate scale, technologies, extensive oral dose form network and expertise to reduce risk, complexity and cost between phases.