Lonza is expanding a preclinical program in Bend, Oregon, to study aseptic spray drying as a way to formulate biologic medicines, including products that require high doses delivered by injection under the skin.
The work has moved beyond proof of concept after Lonza formulated and spray-dried a range of monoclonal antibodies and conjugates at high concentrations. The company is now developing the process further, assessing its use across different types of medicines and working with interested customers to evaluate it.
High-dose biologics can be difficult to administer in small injection volumes. Lonza is investigating whether converting formulations into sterile dried particles could help address challenges involving concentration, stability, delivery and manufacturing. The program covers monoclonal antibodies, antibody-drug conjugates and peptides.
Aseptic spray drying produces powder while maintaining conditions intended to prevent contamination. Lonza said it is studying the approach for biologics that may otherwise be limited by formulation viscosity or other properties affecting subcutaneous delivery.
The company identified several technical issues for further work, including maintaining protein stability, optimizing formulations, processing materials aseptically and developing a process that can be scaled for manufacturing.
François Ricard, Lonza’s head of research and development for advanced synthesis, said the program is intended to broaden delivery options for biologic therapies. Lonza plans to continue technical evaluations and customer validation as it develops its sterile powder capabilities.
The Bend-based initiative draws on the contract manufacturer’s existing work in formulation, analytical testing and particle engineering. Its current phase focuses on developing and assessing the platform rather than supplying a commercial drug product.