Biopharma innovators face increasing pressure to advance biologic drug candidates to IND rapidly without compromising product quality or downstream scalability. Traditional development timelines often exceed 12 months, delaying patient access and increasing costs. This presentation will highlight how Probio’s Express CMC platform enables delivery of toxicology batch drug substance from a single clone in as little as four months, accelerating IND readiness and first-in-human studies. Leon Tian, PhD, Subject Matter Expert at Probio, will present an integrated strategy combining rapid sample production, robust cell line development, process optimization, and early high-concentration formulation screening. A real-world case study will illustrate successful application of this approach.