Lonza makes additional investments in its global particle engineering network for expanded capacity and specialized capabilities. Jet milling and spray dry processing for development are significantly expanded at U.S. and European sites to meet increased demand, according to the company, along with enhanced specialized processing capabilities. The trend towards more highly potent molecules, driven primarily by oncology applications, has resulted in the need for expanded contained particle engineering processing, according to Lonza.
Development capacity (non-GMP assets) is reportedly doubled at the Monteggio (CH) micronization site with investments including a new glove-box for isolation, upgraded process controls and expanded operator teams. A new micronization development wing is also online at the Quakertown, Pa. site. Additionally, a new pharmaceutical spray dryer dedicated to development projects has been added at the Bend, Ore. site.
Lonza also expands its specialized processing capability within its particle engineering platform. During the last 12 months, the Monteggio site has revamped its processing assets to allow for 100% segregation of steroids and hormone compounds, according to the company. Two new cGMP rooms are designed to reach a proper containment level to meet quality and safety requirements maintaining a high throughput of the micronization processes.
“Particle engineering is a key component of our integrated services across drug substance and drug product development and manufacturing,” says Christian Dowdeswell, v.p. small molecules commercial development, Lonza. “We see an increasing requirement for phase-appropriate jet milling and spray drying to advance complex molecules and meet more specialized target product profiles across oral and inhaled applications.”
As part of Lonza’s focus on expanded particle engineering services, the external sale of jet milling equipment and containment systems is curtailed. Going forward, the Monteggio-based engineering and technical team is entirely focused on supporting the delivery of micronization services.
For more information, visit: www.lonza.com