UPPSALA, SWEDEN — Gyros Protein Technologies AB, a pioneer in automated nanoliter-scale immunoassays and a leading provider of peptide synthesizers and reagents, today announced the introduction of Gyrolab® AAVX Titer Kit for adeno-associated virus (AAV) vector titer determination in AAV vector manufacturing. The new Gyrolab AAVX Titer Kit for physical titer determination, one of the critical quality attributes (CQAs) of the FDA process validation guidelines, has a broad applicability across numerous AAV serotypes and adds to the Company’s wide range of ready-to-use kits that are already used by scientists and bioengineers in the rapidly growing cell and gene therapy market, where AAV vectors are commonly used.
Gyrolab AAVX Titer Kit supports scientists in the development and production of cell and gene therapies to maximize performance and productivity, and reduces the time needed to produce patient treatments. With compressed development timelines for these therapies, the new kit generates results four times faster and requires 10 times less sample compared to traditional ELISA methods, accelerating AAV vector workflows and enabling high quality data to be produced from small sample volumes. Featuring an analytical range of >3 logs, Gyrolab AAVX Titer Kit also minimizes repeat testing compared to ELISA.
Gyrolab AAVX Titer Kit is based on a highly selective AAVX affinity ligand developed with the Thermo Scientific™ CaptureSelect™ technology by Thermo Fisher Scientific. These ligands are also the basis of POROS™ CaptureSelect™ AAVX Affinity Resin, which is frequently used to purify AAV viral vectors. The AAVX ligand binds with high affinity and selectivity to native and recombinant AAV particles of various serotypes (AAV1 to AAV8, AAVrh10).
Dan Calvo, president, Gyros Protein Technologies, commented, “The introduction of Gyrolab AAVX Titer Kit is yet another valuable addition to our growing portfolio of ready-to-use kits helping to set a new standard for immunoassays and analytics required to develop and execute an efficient manufacturing process for biotherapeutics that meets regulatory requirements. We continue to see increased adoption rates by researchers seeking automated analysis of bioprocess samples, including for p24 titer. We believe this new kit will support our customers’ efforts in maintaining the CQAs in the process validation of cell and gene therapies and working toward providing safer and more efficacious treatments for patients.”
Gyros Protein Technologies is focused on augmenting immunoassay solutions to help scientists solve analytical challenges during the development, clinical and bioprocess phases of biotherapeutics. By addressing a wide range of applications with Gyrolab kits and Gyrolab assays, the industry is better primed to accelerate workflow timelines, reduce costs, and achieve milestones critical to these therapies.