Lonza has expanded its development and manufacturing offering to include more complex biologic medicines, with a stated goal of preparing some programs for Investigational New Drug applications in as little as six months.
The Swiss contract development and manufacturing company announced the expansion on Oct. 13. It extends pathways introduced earlier this year for monoclonal antibodies to bispecific antibodies, Fc-fusion proteins and high-concentration drug product formulations.
The offering combines drug substance and finished drug product development and manufacturing within a single coordinated program. Lonza said it can deliver drug substance for toxicology studies in as little as three months.
The timelines describe the company’s stated capabilities rather than results reported for a specific customer program. The announcement did not identify participating developers, disclose pricing or provide data comparing the expanded offering with conventional development schedules.
The program integrates cell line development, formulation work, analytical methods and manufacturing. It uses Lonza’s GS Ori Go vectors, which are part of its GS Gene Expression System platform.
Lonza said the approach draws on knowledge from previous development work to address manufacturing and formulation requirements during early development.
High-concentration formulation development is incorporated earlier in the process to address formulation challenges associated with complex biologics and support different administration requirements.
Gordon Bates, Lonza’s head of integrated biologics, said the expansion responds to demand from developers working on more complex therapies.
The company said its coordinated approach is intended to balance development speed with manufacturability, formulation needs and preparation for clinical evaluation across the additional biologic formats.