Lonza Pharma & Biotech has announced the establishment of a Center of Excellence for Dry Powder Inhaler (DPI) drug product development at its Bend (OR) US site.
The DPI service offer leverages the extensive particle engineering expertise and capabilities at Lonza-Bend while incorporating Lonza site network capabilities where applicable for specific customers and/or drug programs.
The core service offer is comprised of a head-to-head evaluation of particle engineering approaches (spray drying and micronisation), along with capsule-based DPI formulation design and development.
Christian Dowdeswell, SVP Lonza Pharma and Biotech, said: “Drug delivery via the lung is an increasingly viable treatment option for a number of therapeutic areas. We have determined a growing market need for service partners that have both particle engineering expertise as well as integrated product development solutions that can effectively advance customer molecules utilizing the DPI format while minimizing program risk and complexity.
As the number of candidate compounds utilising the pulmonary and nasal delivery routes increases, particle engineering capabilities combined with formulation design expertise have become more critical in meeting target product profiles and accelerated development timelines.
Lonza has more than 25 years' experience in particle engineering, formulation and encapsulation for DPI applications across a broad range of drug substance parameters and most commercially viable DPI delivery devices. This experience has been utilised in designing a service package that meets the needs of this critical first decision-making step in DPI formulation design.
Utilising phase-appropriate assets, Lonza scientists can provide capsule-based DPI formulations for feasibility studies in as little as 12 weeks. Analytical services, including initial stability studies, are also available as part of the DPI service package. The service package can be further tailored to individual drug programs with drug substance development and supply, and services for regulatory filing submissions.
Lonza also provides customisable DPI capsules (Capsugel Zephyr capsule portfolio) designed to provide high performance and compatibility between the capsule/device and capsule/formulation.
