Accelerating Timelines to Clinic-The Race to First-In-Human with GPEx® Lightning

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. Download this whitepaper!