Capsugel Expands Micro-Dosing and High-Potency Compound Services
Capsugel, a contract provider of dosage forms and part of Lonza, has expanded its clinical-trial capabilities for micro-dosing and increased development and manufacturing capabilities for specialized drug products using liquid-filled hard capsule (LFHC) technology at its facility in Edinburgh, 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) uses to provide product assessment and Phase I-II clinical-trial material manufacture. The new Xcelodose 600S equipment, which is housed in a dedicated suite designed for handling highly potent active pharmaceutical ingredients, adds to existing Xcelodose capacity at Capsugel’s facilities in Ploërmel, France and Tampa, Florida and is now fully operational.
The expansion at the Edinburgh facility also includes additional high-containment capabilities for handling highly potent and cytotoxic compounds at all stages of product development and manufacturing. The facility, dedicated for the manufacture of liquid- and semi-solid-filled hard capsule pharmaceutical products, is now capable of producing an additional 250 million LFHC dosage forms annually, according to Capsugel.
The expansion, initially announced in 2015, includes the addition of a third cleanroom, quality control, and analytical capabilities as well as 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.