Quantitative Quality Control of Cell-Based Bioassay Performance

摘要

Bioassay, especially cell-based bioassay is the most relevant and closest to real biological systems. The information of cell-based bioassay in biological license application is required by regulatory. Therefore, bioassay data integrity and results quality are critical in both product releasing (Specification testing) and candidate evaluation (Characterization testing). This review article will briefly address some key considerations and strategies in different stages during bioassay life cycle.