Capsugel, a global leader in delivering high quality, innovative dosage forms and solutions, has announced an expansion of its facility in Quakertown (PA, USA) to meet increasing customer demand for its micronization 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.
The micronization of active pharmaceutical ingredients (APIs) is accomplished using proprietary jet milling equipment. 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. The expansion enables the company to add capacity for commercial manufacturing and is expected to further improve product lead times by up to 75%.
“Our customers are increasingly seeking specialized 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. “Micronization and nanomilling 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 commercialization.”
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.
“One of the many reasons we were eager to join Capsugel was the opportunity to become a part of its unique design, development and manufacturing offering,” said Wayne Sigler, President, Powdersize, a division of Capsugel. “This investment further supports the role of micronization and submicronization in compound assessments and product design through commercialization, bringing more benefits to our customers. It also enables us to stay ahead of rising customer demand, so we can help our customers meet aggressive development and clinical timelines.”