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The company will expand its micronization abilities for highly potent drug compounds through this investment.
Catalent announced on Dec. 3, 2020 that it is investing $10 million into isolator capabilities at its facilities in Malvern, PA, in the United States and Dartford, United Kingdom, to increase its micronization abilities for highly potent drug compounds.
The investment will allow for jet milling operations at both sites under containment to a working occupational exposure limit of 0.05 micrograms per cubic meter, permitting micronization of potent and highly potent compounds at less than 10 and less than one microgram per cubic meter, a company press release said. The new venture will also provide the facilities with capabilities to perform in an inert nitrogen environment that provides manufacturing safety, eliminates the risk of dust explosion for compounds with low minimum ignition energy values, and supports the processing of humidity, light, and oxygen-sensitive materials.
Specifically, the Dartford isolator will feature a K-Tron gravimetric feeder with KT35 hopper and feed screws, suitable for 8-inch and 12-inch jet mills, while the Malvern facility will receive a nine-chamber isolator within a new extension at the site, according to the press release.
“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, Catalent, in the press release. “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.”