Last March, the U.S. Food & Drug Administration (FDA) issued updated guidance related to cell therapy characterization, manufacturing and monitoring. Historically, tools that were developed for gene therapies have been repurposed for cell therapy monitoring; however, they have limitations including repeated validation requirements, limited assay sensitivity and suboptimal quantitative accuracy. Several quantitative assays are now available specifically for cell therapy—providing single-cell resolution for quantifying vector copy number, counting therapeutic cells and tracking individual clones. These assays may help improve cell therapy products at every stage, from process development, to manufacturing and patient monitoring.
In this webinar, attendees will dive into the FDA’s latest guidance for monitoring the quality, safety and efficacy of cell therapies and learn how a single-cell assay combined with high-throughput T-cell receptor (TCR) sequencing can provide a next generation solution for characterizing and tracking cell therapies.
Register to gain more insight into the next-generation tools for cell therapy characterization, manufacturing and monitoring.