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Capsugel extends inhaled biotherapeutics delivery capability to Phase 2 clinical trials.
Capsugel announced on May 4 that the company has manufactured Phase 2 clinical trial supplies for a dry powder inhalation (DPI) formulation that delivers biotherapeutics to the lung. The supplies were manufactured by Bend Research, part of Capsugel’s Dosage Form Solutions business unit.
The inhaled dry-powder biotherapeutic, which was developed using particle engineering and spray-drying processing methods, is the first inhalation delivery therapy to be manufactured to Phase 2 scale at the company’s clinical trial manufacturing facility in Bend, OR.
The spray-dry technology and particle engineering provides a stable dry powder with improved aerosol performance and high collection efficiencies, the company reports. The DPI powders will be dosed in a Phase 2 clinical trial in 2015.
Capsugel reports that it will add commercial spray-drying capacity this year, enabling the company to manufacture DPI formulations at commercial scale.