Lonza is expanding development of an aseptic spray drying platform designed to address some of the formulation and delivery challenges associated with highly concentrated biologic drugs. The company says its preclinical program, based at its facility in Bend, Oregon, has moved beyond initial proof-of-concept work and into a broader development phase. The effort is focused on determining how sterile spray-dried formulations could provide additional options for biologics that can be difficult to deliver because of dose requirements, stability, pharmacokinetic considerations or manufacturing constraints.

Initial work demonstrated the ability to formulate and spray dry monoclonal antibodies and conjugates at high concentrations, according to Lonza. The company is now evaluating the technology across a wider range of therapeutic modalities and assessing the technical capabilities that could be needed for future development and manufacturing applications.

A key area of interest is high-dose subcutaneous (SC) delivery. As biologic therapies increasingly move toward more convenient administration, developers face the challenge of delivering larger drug doses without substantially increasing injection volume. Highly concentrated liquid formulations can also present viscosity and stability challenges, creating demand for alternative formulation and delivery approaches.

Lonza is investigating whether spray drying can help address some of these limitations by converting concentrated biologic formulations into sterile powders or suspensions. The company said the approach could potentially improve stability and reduce viscosity compared with some highly concentrated liquid formulations.

The technology remains relatively specialized, however, and several development hurdles must be addressed before it can be broadly applied to biologic drug products. These include maintaining protein integrity during processing, establishing rapid and reproducible aseptic processing methods, optimizing formulations for individual molecules and determining how the process can be scaled for commercial manufacturing.

The research program is drawing on Lonza’s existing capabilities in formulation science, analytical development and particle engineering. The company is evaluating applications across modalities including monoclonal antibodies, antibody-drug conjugates (ADCs) and peptides, while also considering how the technology could complement its existing drug product capabilities.

“We believe aseptic spray drying has the potential to expand drug delivery options for biologics and new therapeutic modalities by addressing challenges associated with stability, dose concentration and patient convenience, but also pharmacokinetics,” says Francois Ricard, head of R&D, Advanced Synthesis at Lonza. “By applying our expertise in formulation science and spray drying, we are advancing approaches that could help customers develop and manufacture the next generation of biologic therapies.”

With the proof-of-concept phase completed, Lonza is moving into dedicated platform development. The next stage will include broader technical evaluations, expansion of sterile powder capabilities and validation activities with interested customers.

The company said it will also continue assessing the capabilities required to support potential customer programs as the platform develops. The work is intended to establish a broader technology base for sterile powder formulations while determining where aseptic spray drying can provide practical advantages within biologic drug development and manufacturing.

For more information, visit www.lonza.com.