Clinical Trial Services and High-Potency Compounds
Capsugel expands capabilities for Clinical Trial Services and High-Potency Compounds at Edinburgh Facility
Capsugel Announces Expanded Capabilities for Clinical Trial Services and High-Potency Compounds at Edinburgh Facility
- New Xcelodose-based micro-dosing capabilities complement Capsugel’s existing offerings in Europe and the United States
- New cleanroom, warehouse and capabilities support the company’s growing pipeline for pharmaceutical customer projects using liquid-filled hard capsule technology
Morristown, NJ (USA), 31 October 2017 – Capsugel, now a Lonza company, a global leader in delivering high-quality, innovative dosage forms and solutions, today 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 industry-leading 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 (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.”
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. With nearly 10 Xcelodose units in the United States and Europe combined, Capsugel offers best-in-class micro-dosing capabilities and capacity for its clients.
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 these 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’s customers benefit from working with one partner to manage their drug product pipeline from bench to full commercial scale – resulting in faster development times and reduced risk, among other benefits.”
CAPSUGEL EXPANDS CAPABILITIES FOR CLINICAL TRIAL SERVICES AND HIGH-POTENCY COMPOUNDS SOURCE:
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About Lonza and Capsugel
Capsugel – now a Lonza company – designs, develops, and manufactures a wide range of innovative dosage forms for the biopharmaceutical and consumer health and nutrition industries. Our unique combination of science, engineering, formulation and capsule expertise enables our customers to optimize the bioav
ailability, targeted delivery and overall performance of their biopharmaceutical and consumer health and nutrition products. We partner with more than 4,000 customers in over 100 countries to create novel, high-quality and customized solutions that align with our customers’ evolving needs and benefit patients and consumers. For more information, visit www.capsugel.com and follow us on Twitter, LinkedIn and YouTube.
Following the closing of the Capsugel acquisition, Lonza further strengthened its position as one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. Lonza harnesses science and technology to create products that support safer and healthier living and that enhance the overall quality of life.
An integrated solutions provider serving the healthcare continuum, Lonza offers products and services from the custom development and manufacturing of active pharmaceutical ingredients to innovative dosage forms for the pharma and consumer health and nutrition industries. In addition to drinking water sanitizers, nutraceuticals, antidandruff agents and other personal care ingredients, the company provides agricultural products, advanced coatings and composites and microbial control solutions that combat dangerous viruses, bacteria and other pathogens.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 50 major manufacturing and R&D facilities and nearly 14,000 full-time employees worldwide. Further information can be found at www.lonza.com.