Capsugel Expands Micro-Dosing Services to Help Accelerate Customers' Product Development Timelines

"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 play a valuable role in pharmaceutical product development by minimizing the cost and time requirements associated with early feasibility work. The company's Xcelodose technology facilitates rapid, automated and consistent PIC/PIB programs. These programs 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 percent. With five Xcelodose units in the U.S. 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 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."

By leveraging its engineering core in the development of proprietary processes and phase-appropriate equipment, Capsugel has positioned itself as a valuable partner in designing and advancing product concepts. The company's speed-to-product toolkit, which facilitates rapid feasibility assessments, includes Capsugel's Xcelodose-based micro-dosing capabilities, in-house micronization/nano-milling expertise for API optimization, additional proprietary bench-scale equipment designed and developed based on science-of-scale studies, and technology selection methodologies based on predictive models that minimize both development time and API requirements.

The company plans to continue innovating and expanding its micro-dosing technology and service offering.

ABOUT CAPSUGEL
Capsugel is a global leader in delivering high-quality, innovative dosage forms and solutions to its customers in the health care industry. The company's Hard Capsule business offers customers the broadest portfolio of gelatin, vegetarian, and other specialized capsule technologies. Capsugel's Dosage Form Solutions (DFS) business utilizes an array of proprietary technologies and specialized manufacturing capabilities to solve customers' most pressing product development challenges, including bioavailability enhancement, modified release, abuse deterrence, biotherapeutic processing, and inhalation formulation. The company's fast-to-clinic program streamlines product development from pre-formulation through clinical and commercial supply for finished dosage forms. Headquartered in Morristown, N.J., Capsugel serves more than 4,000 customers in more than 100 countries. For additional information, visit www.capsugel.com.

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