The dosage forms solutions company has completed the manufacture of Phase II supplies of an inhalation delivery therapy from its clinical trial manufacturing (CTM) facility in Bend, Oregon.
While the Capsugel could not disclose the customer nor the molecule, David Lyon, Head of Biotherapeutic Formulation and Processing, told us this was the first time the plant has manufactured an inhaled dry-powder biotherapeutic to Phase II scale, and could demonstrated the advances in such technology.
"The industry has advanced substantially in delivery of large molecules to the lung using differentiated technologies," he explained. "The key challenge that we have addressed is the ability to engineer the particle for lung delivery rather than via injection."
Capsugel acquired the facility when it bought Bend Research in 2013, and Lyon said the combined entity now has "expertise in spray-dried dispersion technology," meaning the firm can now manufacture engineered particles for efficient delivery to the lung.
"By advancing our offering to include specialized DPI capsules and now clinical manufacturing supplies for biotherapeutic compounds, we are bolstering our ability to help customers bring these innovative therapies to market to benefit patients."
Capsugel invested $20m in Bend in November 2013 to add commercial spray drying capacity, and Lyon siad this will be coming online later this year. "We will soon be able to manufacture at commercial scale for DPI formulations as well."