Cell and Gene Therapy web

Gyrolab immunoassays for 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.

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Learn more about Gyrolab immunoassays for cell and gene therapies

Gyrolab p24 Kits, Gyrolab AAVX Kits, and Gyrolab AAV9 Kits provide plug and play, miniaturized lentiviral p24 titer, and AAV titer immunoassays for use on all Gyrolab platforms. Kits include everything needed to generate 96 or 4800 data points, including capture reagent, detection reagent, standard curve samples, wash buffer, sample dilution buffer, and Gyrolab Bioaffy CD(s). Used together with Gyrolab systems, 96 data points are delivered in 80 minutes to accelerate viral vector bioanalysis during production and bioprocessing.

Gyrolab systems meet all these criteria for advanced gene therapy bioanalytical assay performance and speed needed to succeed in cell and gene therapy development. Gyrolab systems are well established in pharma and both preclinical and clinical CROs and support a wide range of applications.

 

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Ask an expert how Gyrolab platform can help maximize immunoassay speed and quality in cell and gene therapy development.

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Application Note: High-throughput, automated analysis of viral vector titer and process-related impurities

Learn how the Gyrolab® xPand immunoassay system by Gyros Protein Technologies provides automated and high-throughput assays, saving considerable hands-on time for viral vector titer and impurity immunoassays.

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