Combines its proprietary Xcelodose technology with best practices established at Xcelience and now offers micro-dosing capabilities in both North America and Europe
Capsugel, a US manufacturer of dosage forms and solutions, is expanding its micro-dosing services to include early-phase feasibility work.
The Morristown, NJ-headquartered firm is combining its proprietary Xcelodose precision powder micro-dosing systems with powder-in-capsule/powder-in-bottle (PIC/PIB) expertise developed at Xcelience, which Capsugel acquired in January this year. By replicating the expertise developed at Xcelience's operations in Tampa, Florida and at Capsugel's product development and manufacturing facility in Ploërmel, France, the firm says it can now offer its micro-dosing capabilities in both North America and Europe.
'Today's announcement builds on Capsugel's track record of engineering excellence while demonstrating our ability to integrate new capabilities for the benefit of our customers,' said Amit Patel, President, Capsugel Dosage Form Solutions.
'By leveraging best practices pioneered by Xcelience, an array of Xcelodose technologies and our high-containment capability, we have further strengthened our speed-to-product toolkit, enabling us to deliver even greater value to our customers.'
Capsugel's micro-dosing services help minimise the cost and time requirements associated with early feasibility work. The company's Xcelodose technology facilitates rapid, automated and consistent PIC/PIB programmes, which remove the need for excipient compatibility and stability studies for Phase I evaluations, allow for the rapid screening of API candidates, and reduce early-stage product development time by as much as 45%. With five Xcelodose units in the US and two in Europe – including Capsugel's recently added isolator capability in Ploërmel – the company can handle highly potent active pharmaceutical ingredients (HPAPIs) up to occupational exposure bands (OEB) 4–5 in both North America and Europe.
'This is exactly the type of exciting opportunity we envisioned when we joined forces with Capsugel,' said Derek Hennecke, President, Xcelience, a division of Capsugel Dosage Form Solutions.
'Over the past decade, Xcelience has developed an unrivalled proficiency in micro-dosing, producing more than 600 PIC/PIB batches. As part of Capsugel, we can now extend our expertise to a broader set of customers, while helping to bring Capsugel's early-phase design and development offerings to a whole new level.'