Bioanalytical Assay Strategies And Considerations For Measuring Cellular Kinetics

Drug development has been evolving dramatically over the past several decades to counter the unmet challenge of previously untreatable diseases. Novel and refined technologies have propelled drug developers beyond small molecule therapeutics and simple biologics (e.g., monoclonal antibodies) into highly complex, large-molecule drugs. Of these complex modalities, the class of cell and gene therapies has progressed exponentially over the last several years, resulting in successful regulatory approvals of several cell and gene therapies for various treatment indications. One such indication is immune oncology; the interplay of the immune system and diseases such as cancer or autoimmunity has led to many breakthroughs in immunotherapy. Additionally, advancements in gene editing techniques and transgene delivery systems are leading to breakthroughs in patient care. Various gene and cell therapy programs have shown great promise for treatment of a multitude of diseases including those in rare disease and difficult to treat cancers.