PK Assessment for Advanced Modalities (Cell & Gene Therapies)
The last few decades have seen a surge of new cell and gene therapies in drug development pipelines. The bioanalytical support for these complex modalities is evolving as stakeholders continue to learn the unique considerations for these drugs. ELISpot is among the emerging technologies being applied to such programs and is used to evaluate cellular immunogenicity in both preclinical and clinical settings. There are limited alternatives to this approach, making ELISpot a growing area of work for bioanalytical labs. However, with no official guidelines from regulatory authorities, ELISpot assays and the practices associated with implementing these methods can vary widely.
ELISpots are being used more frequently in regulated bioanalysis. This webinar investigates the current status of these assays, challenges for use in a regulated setting and the practical applications of this methodology.