Catalent, a global leader in enabling health partners to optimize patient treatments, announced Tuesday it has completed a $10 million expansion in state-of-the-art large-scale isolator units at its Malvern, Pa., and Dartford, U.K. facilities that will provide advanced containment capabilities for the micronization of highly potent drug compounds.
The new hard-wall isolator systems will allow for clinical to commercial scales jet million operations to be carried out under enhanced containment conditions. Micronizers purged with nitrogen can be installed within the isolators to increase manufacturing safety by eliminating the risk of dust explosion for compounds with low minimum ignition values. The upgrades also allow for greater efficiency by using a continuous milling operation, eliminating the need to stop and change out materials. Clean-in-place (CIP) automated washing systems also reduce manual operator intervention and accommodate flexible sampling schemes without needing external equipment, the company said.
“Micronization is a well-established technology to help improve the solubility of oral drugs, and there continues to be a growing need for safe manufacturing and containment technologies required for the development of highly potent APIs,” said James Walter, vice president of Operations, Oral and Specialty Delivery at Catalent. “These expansions provide the increased capacity needed to meet current and future demand for high potent, high value micronization.”
The Malvern and Dartford sites offer expertise in particle size engineering technologies, including micronization, jet million, mechanical milling, cryogenic milling, and associated analytical services. Both also work alongside the company’s network of commercial-scale manufacturing facilities.