Lonza, a global contract development and manufacturing organisation (CDMO), has announced that it is advancing a preclinical aseptic spray drying programme to provide biopharmaceutical companies with additional formulation and delivery options for biologics that face limitations related to high-dose subcutaneous administration, pharmacokinetics, stability or manufacturability.
The initiative builds on proof-of-concept work demonstrating the formulation and spray drying of a range of monoclonal antibodies and conjugates at high concentrations.
The programme, based in Bend, US, is focused on new approaches for biologics, including high-dose subcutaneous (SC) therapies, an area where current delivery options remain limited. As demand grows for patient-friendly biologic treatments, drug developers are seeking solutions to deliver higher doses in smaller injection volumes.
Aseptic spray drying remains a specialised technology with limited adoption across the industry. Lonza has combined its formulation science, analytical capabilities and particle engineering expertise to develop a spray drying platform for proof-of-concept studies.
The approach is being investigated for a range of therapeutic modalities, including monoclonal antibodies, antibody-drug conjugates (ADCs) and peptides.
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
The research aims to address key biologics development challenges, including stability, dose concentration, pharmacokinetics and manufacturability. While spray drying offers potential advantages, such as improved stability and reduced viscosity in highly concentrated formulations through suspensions, technical challenges remain. These include maintaining protein stability, rapid and reliable aseptic processing, formulation optimisation and scalable manufacturing.
Francois Ricard, Head of R&D, Advanced Synthesis at Lonza, said: “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. 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.”
Following the proof-of-concept work, the programme is moving into dedicated development to expand sterile powder capabilities across a broad range of modalities, including existing drug product capabilities, while supporting interested customers.
During this phase, Lonza will focus on platform development, technical evaluation and validation with interested customers, while continuing to assess the capabilities that may be required to support future customer needs.
