Capsugel has manufactured Phase II clinical trial supplies for a dry powder inhalation (DPI) formulation that delivers biotherapeutics to the lung using a combination of formulation, particle engineering and spray-drying processing methods. The supplies were manufactured by Bend Research, part of Capsugel’s Dosage Form Solutions business unit. The inhaled dry-powder biotherapeutic is the first inhalation delivery therapy to be manufactured to Phase II scale at the company’s clinical trial manufacturing (CTM) facility in Bend, OR.
 
These DPI powders will be dosed in a Phase II trial this year, and with additional commercial spray-drying capacity coming online this year, the company will be able to manufacture at commercial scale for DPI formulations.
 
“While drug delivery via the lung traditionally has been limited to the local treatment of respiratory diseases, there is growing interest in using these technologies for systemic delivery across a wider range of therapeutic areas, such as infectious disease and genetic disorders,” said David Lyon, head of Biotherapeutic Formulation and Processing, Capsugel Dosage Form Solutions. “For 15 years, we have worked at various stages of inhalation therapy development. 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.”