Catalent has completed a $10 million expansion in state-of-the-art large-scale isolator units at its Malvern, Pennsylvania, and Dartford, U.K., facilities, according to a Tuesday announcement.
The Somerset-based biopharma leader said the new hard-wall isolator systems at both sites allow for clinical to commercial scale jet milling operations to be carried out under enhanced containment conditions, with occupational exposure limit values as low as 0.05 micrograms per cubic meter.
The upgrades will provide advanced containment capabilities for the micronization of highly potent drug compounds. Micronizers purged with nitrogen can be installed within the isolators for increased manufacturing safety, eliminating the risk of dust explosion for compounds with low minimum ignition values.
Additionally, greater efficiency can be achieved by utilizing a continuous milling operation, eliminating the need to stop and change out material. Clean-in-place automated washing systems further reduce manual operator intervention, as well as accommodate flexible sampling schemes without the need for external equipment.
“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,” commented James Walter, vice president, 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.”
