Capsugel has announced that it has manufactured Phase 2 clinical trial supplies for a dry powder inhalation (DPI) formulation that efficiently delivers biotherapeutics to the lung. The supplies were manufactured by Bend Research, part of Capsugel’s Dosage Form Solutions business unit.
Utilizing a combination of unique formulation, particle engineering and spray-drying processing methods, the inhaled dry-powder biotherapeutic is the first inhalation delivery therapy to be manufactured to Phase 2 scale at the company’s clinical trial manufacturing (CTM) facility in Bend, Ore.
“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.”
Capsugel continues to innovate the development of customized formulations for DPI therapeutics, offering customers comprehensive solutions to address inhalation delivery challenges. Using spray-dry technology, Capsugel provides unparalleled particle engineering for inhalation.
This results in a stable dry powder with improved aerosol performance and high collection efficiencies. These DPI powders will be dosed in a Phase 2 clinical trial this year, and with additional commercial spray-drying capacity coming online this year, Capsugel will soon be able to manufacture at commercial scale for DPI formulations as well.
“Our clients continue to seek innovative and integrated solutions to their formulation challenges,” said Amit Patel, President, Capsugel Dosage Form Solutions. “Advancing our inhalation formulation offering to Phase 2-scale GMP supplies - through the use of our specialized equipment, formulation know-how and capsule expertise - represents another way in which Capsugel is collaborating with customers on the development of better medicines for patients.”