Accelerating Timelines to Clinic-The Race to First-In-Human with GPEx® Lightning
Summary: The time invested in bringing an investigational biological drug to Phase 1 clinical studies can be intense making it increasingly important to harmonize technological innovation with biomanufacturing requirements. This process begins at the cell line development stage. Key factors of cell line expression systems that can support Phase 1 studies through commercial manufacturing include (1) genetic stability, (2) consistent product expression, and (3) reproducible product quality. When these criteria are met, they have the propensity to generate cell line expression platforms yielding stable, high-expressing biologics during the manufacturing process. This underscores the importance of cell line development in creating a standardized platform that can deliver consistent results across a variety of biological products. With GPEx® Lightning pools serving as an early predictive indicator, the resulting time savings, and increased confidence in identifying the optimal candidate for biomanufacturing provides a solution in speed to first-in-human and the delivery of quality high-titer products.