Capsugel announced expanded clinical trial capabilities, as well as increased development and manufacturing capabilities for specialized drug products utilizing liquid-filled hard capsule (LFHC) technology, at its Edinburgh facility in Scotland.
Capsugel is enhancing its micro-dosing services offering for early-phase cGMP manufacturing at its Edinburgh facility. The company is combining its proprietary Xcelodose Precision Powder Micro-Dosing Systems with powder-in-capsule/powder in bottle (PIC/PIB) to provide rapid product assessment and Phase I-II clinical trial material manufacture. The Xcelodose 600S equipment, which is housed in a dedicated suite designed for handling APIs, complements existing Xcelodose capacity at Capsugel’s Ploërmel (FR) and Tampa, FL (USA) facilities and is now fully operational.
“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 Capsugel’s Edinburgh facility. “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 company’s Xcelodose technology facilitates rapid, automated and consistent PIC/PIB programs that eliminate the need for excipient compatibility and stability studies for Phase I evaluations, allow for the rapid screening of API candidates, and can reduce early-stage product development time by as much as 45 percent.
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.
The expansion, initially announced in 2015, includes the addition of a third cleanroom, quality control and analytical capabilities, and a 5,000-square-foot GMP environmentally controlled 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, and a capsule banding unit. With these enhancements, the facility is equipped to make complex formulations feasible from containment, bioavailability and/or targeted delivery perspectives.