Capsugel announces expanded capabilities for clinical trial services and high-potency compounds at Edinburgh facility.
New cleanroom, warehouse, and capabilities support the company’s pipeline for pharmaceutical projects using liquid-filled hard capsule technology.
Capsugel, a Lonza company, 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.
Enhanced Clinical Trial Services Offering
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) expertise to provide rapid 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 APIs, complements existing Xcelodose capacity at Capsugel’s Ploërmel (France) and Tampa, FL 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.”
Capsugel’s micro-dosing services play a valuable role in pharmaceutical product development by minimizing the cost and time requirements associated with early phase development and cGMP manufacturing.
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.
Expanded High-Potency Compound Capabilities
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, which is the largest dedicated site in the world 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.
The expansion, initially announced in 2015, includes the addition of a third cleanroom, state-of-the-art 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 the enhancements, the facility is equipped to make complex formulations feasible from containment, bioavailability, and/or targeted delivery perspectives.
“As highly potent and cytotoxic drugs become increasingly prevalent in the drug development pipeline, our customers are turning to us for LFHC technology, specialized high-containment facilities, and expertise that complies with heightened regulatory and operational requirements,” Fraser said.
Capsugel, now a Lonza company, designs, develops, and manufactures a range of dosage forms for the biopharmaceutical and consumer health and nutrition industries.