Expansion enables the pharmaceutical solutions company to add capacity for both pilot scale and commercial pharmaceutical ingredients manufacturing
Dosage forms company Capsugel is expanding its facility in Quakertown, Pa., to meet increasing demand for its micronisation services for both clinical and commercial manufacturing. The company will double the size of its current pilot-scale capacity for clinical trial quantities and increase the number of suites dedicated to commercial manufacturing.
In addition to enabling increased capacity, the added suites will feature new state-of-the-art, single-use containment technologies to accommodate continued growth in potent and highly potent compounds.
The new equipment and suites are scheduled to be operational by January 2017, and the expansion is expected to further improve product lead times by up to 75%.
The Quakertown facility, which Capsugel acquired as part of its purchase of Xcelience and Powdersize in January 2016, operates as a full-service provider of particle-size reduction and particle-size control/classification technologies for pharmaceutical customers.
The acquisition expanded the company’s suite of bioavailability enhancement tools aimed at improving the bioavailability of APIs with either dissolution or solubility challenges – an issue faced by more than 70% of new chemical entities.
Micronisation of active pharmaceutical ingredients (APIs) is accomplished using proprietary jet milling equipment.
'Our customers are increasingly seeking specialised partners in early-stage compound assessments and product design, with poor dissolution and/or solubility often being at the forefront of their challenges,' said Amit Patel, Sr Vice President, Capsugel.
'Micronisation and nano-milling technology is a significant component of Capsugel’s overall service offering, and this investment further strengthens our ability to rapidly advance challenging compounds to clinic and ultimately commercialisation.'
'This investment further supports the role of micronisation and sub-micronisation in compound assessments and product design through commercialisation,' added Wayne Sigler, President, Powdersize, a division of Capsugel.
'It also enables us to help our customers meet aggressive development and clinical timelines.'
The company adds: 'Our single use, contained collection systems are designed to decrease turnaround time while also significantly decreasing potential operator exposure, especially during the cleaning process.
'This will be increasingly important as we trend toward higher-potency compounds.'
Micronization will continue to be done on custom-built jet mills, its says.