Capsugel is expanding its micro-dosing services offering for early-phase feasibility work
Capsugel is combining its Xcelodose Precision Powder Micro-Dosing Systems with powder-in-capsule/powder-in-bottle (PIC/PIB) technology developed at Xcelience, which Capsugel said it acquired in January.
By replicating the technology from Xcelience’s operations in Tampa, at Capsugel’s product development and manufacturing facility in Ploërmel, France, the company said it can now offer micro-dosing capabilities in both North America and Europe.
Amit Patel, president, Capsugel Dosage Form Solutions, said: “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 said its Xcelodose technology facilitate 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%.
The company can now handle highly potent active pharmaceutical ingredients (HPAPIs) up to occupational exposure bands (OEB) 4-5 in both North America and Europe.
Derek Hennecke, president, Xcelience, said: “This is exactly the type of exciting opportunity we envisioned when we joined forces with Capsugel.
“Over the past decade, Xcelience has developed an unrivaled 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.”