Cell-based Testing in Central Laboratories
Outsourcing is a growing trend in the pharmaceutical industry. Demands for central laboratory testing using complex cell-based assays throughout all phases of drug development are on the rise, and central laboratories have realised an augmented role in establishing, validating, and implementing cellular methods. Historically, conducted in- house or at small speciality laboratories, cell-based assays have become essential in large clinical trials, where many subjects are enrolled in multiple geographical locations with numerous sampling timepoints. Carla G. Hill and Thomas W. Mc Closkey at ICON Central Laboratories, explain the current trend is to implement novel cell-based assays, including advanced flow cytometry testing, in a central laboratory setting to standardise assessments and meet regulatory requirements for exploratory biomarkers and surrogate endpoints in clinical trials.