The new offering provides clinical and commercial manufacturing services at a kilogram scale from Lonza’s Bend, US site, home to Lonza’s center of excellence for respiratory delivery.
Kimberly Shepard, Director, respiratory delivery at Lonza, commented: “Pulmonary delivery of solid protein formulations using a dry powder inhaler is a growing trend among drug developers.
“Our new clinical offering further strengthens our world-leading spray-drying expertise and provides manufacturing capacity from early-phase to commercial supply. This expertise and capability enable our customers to bring innovative new medicines to patients with unmet medical needs.”
In the past, the respiratory drug pipeline was primarily dominated by small molecules. However, today approximately 30% of therapies in this pipeline are biologics, with anticipated growth to 50% by 2030, Lonza said.
The administration of protein-based therapies to treat respiratory disease has historically been limited to intravenous or subcutaneous injections, which require frequent and costly administration and rely on patient compliance.
The focused and local delivery method of a solid protein formulation to the lung offers a viable alternative that can also reduce dose and off-target exposure.
Shelf-stable dry powder inhalers can also improve patient access by reducing reliance on cold chain logistics.
Building on than 20 years of experience in spray-drying of biologics, such as monoclonal antibodies (mAbs), oligonucleotides and peptides, Lonza views its expansion into spray-drying of biologics as a logical next step in its operations.