Capsugel Expands Clinical Trial Services at UK Manufacturing Facility

Nov 02, 2017
By Pharmaceutical Technology Editors

Capsugel announced on Oct. 31, 2017 that it expanded clinical trial capabilities, as well as increased development and manufacturing capabilities for specialized drug products using liquid-filled hard capsule (LFHC) technology, at its Edinburgh facility in Scotland.

Previously announced in 2015, the expansion includes a third cleanroom, quality control and analytical capabilities, and a 5,000-ft2 GMP warehouse for additional storage capacity. The expansion also includes new isolators for high containment pre-dispensing and compounding, high- and low-shear compounding and holding tanks, an additional high-speed encapsulation machine, a capsule banding unit, and added high-containment capabilities for handling highly potent and cytotoxic compounds at all stages of product development and manufacturing.

According to the company, it is combining its patented Xcelodose precision powder micro-dosing systems with powder-in-capsule/powder-in bottle capability to provide improved product assessment and Phase I-II clinical trial material manufacture. The new Xcelodose 600S equipment, located in a suite designed for handling highly potent APIs, is now fully operational, and is also used at company facilities in Ploërmel, France and Tampa, FL.

“We are pleased to add API-in-capsule micro-dosing services to our clinical services offering at our Edinburgh facility,” said Jane Fraser, site head at the Edinburgh facility, in a company press release. “By adding new Xcelodose-based micro-dosing capabilities to our traditional liquid-filled hard capsule technology and high-potency capabilities, we are providing our customers with industry-leading solutions for rapid feasibility assessments and early stage clinical evaluations for their drug pipelines.”

The Edinburgh facility expansion also includes additional high-containment capabilities for handling highly potent and cytotoxic compounds at all stages of product development and manufacturing. The facility is now capable of producing an additional 250 million LFHC dosage forms annually, according to the company.

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