Demand for potent, precise therapies and innovative mechanisms of action has fueled the rise of monoclonal antibodies (mAbs), bispecifics, and other complex multi-chain biotherapeutic formats. This growing need puts mounting pressure on developers to move quickly from discovery to IND submission.
One of the most critical and often underestimated bottlenecks is the timely generation of toxicology (tox) data, a key milestone for IND submission and investor decision-making. To generate this data, developers must first secure tox-grade material, and delays at this stage can derail clinical timelines and jeopardize funding opportunities. Without a rapid, risk-mitigated approach to tox material supply, early development becomes vulnerable to costly setbacks.
This white paper introduces Lonza’s rapid tox solutions, designed to accelerate delivery of non-cGMP material for tox studies for mAbs and bispecifics in as little as 2.5 months post-transfection. Drawing on decades of experience and enabling technologies, Lonza outlines how drug developers can streamline early development, reduce risk, and reach IND faster.
Why Read This White paper?
- Learn how to overcome delays in tox material generation that can often stall IND timelines.
- Discover how earlier tox data can unlock critical financial milestones and investor confidence.
- Explore flexible workflows that adapt to molecule complexity, resource constraints, and strategic goals.
- See how Lonza’s integrated platform, from cell line to formulation development, can support your path to clinic.