Somerset, NJ-based Catalent announced Tuesday that it has completed a $10 million expansion in state-of-the-art large-scale isolator units at its Malvern, Pennsylvania, and Dartford, UK, facilities, to provide advanced containment capabilities for the micronization of highly potent drug compounds.
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 (OEL) values as low as 0.05 micrograms per cubic meter. 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 (CIP) 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.”
Catalent’s Malvern and Dartford sites both offer world-leading expertise in particle size engineering technologies including micronization, jet milling, mechanical milling, cryogenic milling and associated analytical services, and work alongside its network of commercial-scale manufacturing facilities. The company recently announced the launch of its Xpress Pharmaceutics solution, an advanced development offering that integrates formulation development with clinical manufacturing, regulatory support and clinical testing, to help achieve flexible and efficient first-in-human studies and fast development.