Facility to manufacture bioavailability-enhancing spray dried dispersion (SDD) drug product intermediates and finished dosage forms
Lonza has enhanced its offering for customers in the early phases of their clinical trials by adding a dedicated early phase clinical manufacturing facility at its small molecules site in Bend, Oregon.
This new facility provides additional capacity for solutions to complex bioavailability challenges in clinical projects. Additionally, capabilities for development and clinical manufacture have been added.
This enables Lonza to speed up product delivery, which is crucial in its customers' rapid journey towards clinical trials.
The facility features eleven suites in total, seven of which are GMP processing suites, and provides enhanced capabilities for development and clinical manufacture of drug product intermediates and drug products.
This includes spray dried dispersion (SDD) powders for oral delivery, dry granulation using a Gerteis roller compactor and compression into immediate release (IR) dosage forms through a Korsch tablet press and Vector LDCS coater.
The facility also features an in-plant viewing area where customers can observe the development of their products.
Additional developments to the facility are already underway. Towards the end of 2022, Lonza anticipates adding a second spray dryer specifically designed for the manufacturing of engineered particles for inhalation as well as encapsulation equipment for encapsulated drug product to the processing suites.
Paul Granberry, Executive Director, Site Head Bend, Lonza Small Molecules, commented: “We continue to observe strong demand from customers for providing early phase development support under accelerated timelines. With this dedicated facility, we further enhance our capabilities in this specific segment with improved speed of delivery.”
Jason Bertola, Executive Director, Commercial Development, Lonza Small Molecules added: “Adding seven GMP processing suites with state-of-the-art equipment to an expert team greatly enhances Lonza’s ability to solve the complex bioavailability challenges of our customers. The increased capacity and capability provided will increase flexibility and benefit customer timelines.”
Lonza’s facility in Bend serves as the company’s Center of Excellence for bioavailability enhancement and inhaled delivery for the Small Molecules business unit.
The Bend team has a been at the forefront of advancing spray-drying and other particle engineering approaches to address solubility and other complex drug formulation and manufacturing challenges. Such challenges are typical for customers in their early clinical development phase.