08 Jul 2020
Lonza Establishes Center of Excellence for Integrated Dry Powder Inhaler Product Development Services
  • Lonza establishes a new Center of Excellence to leverage its core particle engineering expertise utilizing both particle size reduction and spray drying technologies
  • New services are specifically designed for streamlining formulation development for feasibility and early-stage clinical studies
  • Lonza also establishes an evaluation methodology to determine best particle engineering technology and formulation approach to meet the target dry powder inhalation (DPI) product profile

Quote from Christian Dowdeswell, SVP Lonza Pharma and Biotech:

“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.”

Quote from Herbert Chiou, Subject Matter Expert – DPI Formulations

“The key challenge for respiratory delivery remains the ability to engineer stable drug particles. We provide DPI formulation services based on our vast experience in particle engineering, formulation design and encapsulation techniques tailored to the target product profile and delivery device.”

Basel, Switzerland, 08 July 2020 – Lonza Pharma & Biotech announced the establishment of a Center of Excellence for Dry Powder Inhaler (DPI) drug product development at its Bend (OR) USA 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 micronization), along with capsule-based DPI formulation design and development.

As the number of candidate compounds utilizing 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 utilized in designing a service package that meets the needs of this critical first decision-making step in DPI formulation design.

Utilizing 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 customizable DPI capsules (Capsugel® Zephyr™ capsule portfolio) designed to provide high performance and compatibility between the capsule/device and capsule/formulation.

More details can be found here.