- Lonza has expanded its accelerated DNA-to-Investigational New Drug (IND) offering to include non-monoclonal antibody biologics, including bispecific antibodies, Fc-fusion proteins, and high-concentration drug product formulations.
- The integrated development pathway can deliver toxicology drug substance in as little as three months and IND readiness in as little as six months.
Lonza has expanded its accelerated DNA-to-Investigational New Drug (IND) offering to support non-monoclonal antibody (mAb) biologics, including bispecific antibodies, Fc-fusion proteins, and high-concentration drug product formulations. The expansion builds on the company’s earlier introduction of accelerated development pathways for monoclonal antibodies and aims to help developers advance a broader range of biologics toward clinical evaluation.
The offering combines drug substance and drug product development within a coordinated program. It integrates cell line development, formulation development, analytical methods, and drug substance and drug product manufacturing. According to Lonza, the pathway can deliver toxicology drug substance in as little as three months and IND readiness in as little as six months.
The expanded offering uses new GS Ori Go® vectors as part of Lonza’s GS Gene Expression System® platform, drawing on more than 30 years of experience. The company applies prior knowledge-based approaches from the outset to support development progress and manage risk. High-concentration formulation development is also incorporated earlier in the process to address formulation requirements and evolving administration needs.
“The expansion extends reduced development timelines to more complex biologic formats, including bispecific antibodies, Fc-fusion proteins, and high-concentration formulations. Integrating drug substance and drug product development into one pathway is intended to help customers address evolving development needs and progress biologics toward clinical evaluation with greater speed and confidence.”
Gordon Bates, head of Integrated Biologics at Lonza
