Faster immunoassays throughout cell and gene therapy development

Immunoassays are an essential bioanalysis tool used throughout cell and gene therapy development and manufacturing to evaluate viral vector titer. The two most commonly used vehicles for introducing genetic therapies into mammalian cells are adeno-associated virus (AAV) and lentivirus vectors, consequently AAV titer and lentiviral titer ELISA assays are commonly developed for this purpose. However, lengthy assay development and sample analysis time using traditional ELISA methods often causes delays in program schedules.

Utilization of robust and innovative immunoassay platforms for bioanalysis in gene therapy development remains a critical need to generate high quality data and support efficient method development including the use of tools such as design of experiments (DOE), data driven decision-making, and release tests for both CMC and final product manufacturing.

Gyrolab^® automated microfluidic, nanoliter-scale immunoassay solutions dramatically shorten time to results to within one hour, use reduced sample volumes, and improve data quality for AAV- and lentivirus-based gene therapy immunoassays during development, and are ideally suited for compressed cell and gene therapy development timelines.