The hard-wall isolator systems at both sites allow for clinical to commercial scale jet milling operations to be carried out under containment conditions
Catalent, a service provider for biopharma, cell, gene, and consumer health partners, has completed a $10m expansion in large-scale isolator units at its Malvern, Pennsylvania, and Dartford, UK, facilities, to provide containment capabilities for the micronisation of highly potent drug compounds.
The hard-wall isolator systems at both sites allow for clinical to commercial scale jet milling operations to be carried out under containment conditions, with occupational exposure limit values as low as 0.05 micrograms per cubic meter. Micronisers 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 reportedly be achieved by utilising a continuous milling operation, eliminating the need to stop and change out material. Clean-in-place (CIP) automated washing systems are included to further reduce manual operator intervention, as well as accommodate flexible sampling schemes without the need for external equipment.
“Micronisation 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, VP 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 micronisation.”
The company recently announced the launch of its Xpress Pharmaceutics service, a development offering that integrates formulation development with clinical manufacturing, regulatory support and clinical testing.