Accelerated Tox Offerings: A Recipe For Streamlining IND Applications

By Alejandro Fernandez-Martell, Ph.D., Principal Scientist, Global Process Development

Today's biotech landscape demands rapid drug development, making swift progress to IND/CTA status a crucial scientific and financial milestone. Collaborations with CDMOs to accelerate this process highlight rapid toxicology (tox) material supply as a new critical path.

The biopharma industry has seen significantly reduced DNA-to-IND timelines for mAbs, with FIH applications now taking months instead of years (e.g., Lonza’s Ibex® Design for mAbs aiming for 11 months). This acceleration puts pressure on toxicology studies, requiring completion within a tight four- to five-month timeframe. Consequently, timely toxicology data is becoming the next bottleneck.

Lonza has launched two new rapid tox offerings to address this. These solutions accelerate toxicology material generation, essential for initiating safety studies, by up to 50% compared to typical mAb IND timelines. Reducing material generation from five to 2.5 months without affecting CMC activities, these offerings aim to exceed customer expectations and meet evolving market demands.