Catalent is investing $10 million in isolator capabilities at its sites in Malvern, PA and Dartford, U.K., to expand its micronization 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 meter, enabling micronization of potent and highly potent compounds, at less than 10 and less than 1 microgram per cubic meter respectively. 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. Installation and validation activities are expected 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 U.S. The multi-chamber design, undertaken by FPS Architects & Engineers Limited, offers improved ergonomics and is optimized 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 micronization is an important engineering step for many materials to help improve the solubility of oral drugs and optimize inhaled therapies,” commented James Walter, Vice President Operations, 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.”