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Catalent has expanded its Malvern, Pennsylvania, USA, and Dartford, UK, facilities to provide advanced containment capabilities for the micronization of highly potent drug compounds.
Catalent announced on Jan. 25, 2022 that it has completed its $10 million expansion of its Malvern, Pennsylvania, USA, and Dartford, UK, facilities to provide advanced containment capabilities for the micronization of highly potent drug compounds.
The newly expanded large-scale isolator units at both sites will enable the company to perform clinical to commercial-scale jet milling operations under enhanced containment conditions, with low (0.05 micrograms per cubic meter) occupational exposure limit (OEL) values. Additionally, increased manufacturing safety can be achieved by installing micronizers that are purged with nitrogen, thus eliminating the risk of dust explosion from compounds that have low minimum ignition values.
Furthermore, the company reports that through utilization of a continuous milling operation, it is possible to achieve greater efficiency by avoiding the need for stoppages and changing out of materials. Manual operator intervention is further reduced by the clean-in-place automated washing systems, which also 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,” said James Walter, vice-president Operations, Oral and Specialty Delivery at Catalent, in the press release. “These expansions provide the increased capacity needed to meet current and future demand for high potent, high value micronization.”