From DNA To IND In 6 Months: Accelerated Development Backed By Experience

By Dr. Megan Mason, Global CMC Process Development Lead, and Dr. James Berry, Global CMC Strategy and Process Development Technical Director, Lonza

The pressure to reach IND readiness faster has made compressed biologics development timelines increasingly important, with sponsors seeking to reduce delays while maintaining quality, scalability, and regulatory readiness. Achieving this requires early alignment across molecule design, cell line development, process optimization, analytics, formulation, manufacturing, and regulatory activities.

Risk can accumulate across development, particularly when molecules lack early developability assessment, platform processes fail to address product-specific needs, analytical strategies remain underdeveloped, or communication and knowledge transfer are fragmented. Addressing these risks early enables teams to identify bottlenecks, reduce rework, and make critical decisions sooner.

Integrated development models can accelerate timelines by running activities in parallel and leveraging platform technologies, automation, high-throughput screening, and established analytical approaches. Advances in cell cloning, vector design, stable pool development, purification, formulation screening, and process development can further reduce material requirements and shorten key milestones. Early toxicology material generation can also provide critical data sooner, supporting risk reduction and investment decisions.

Ultimately, rapid progression to IND depends on coordinating technical and regulatory functions from the outset. A flexible, integrated strategy can compress development timelines to as little as six months while maintaining product quality, process reliability, analytical readiness, and a scalable foundation for subsequent clinical and commercial manufacturing.