Gyros Protein Technologies introduces Gyrolab AAVX Titer Kit to support cell and gene therapy market
Ready-to-use kit enables rapid adeno-associated virus (AAV) titer determinations during the manufacture of AAV vectors
Uppsala, Sweden, 02 September 2020: 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 4 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.
Gyros Protein Technologies enables peptide synthesis and bioanalytical solutions that help scientists increase biomolecule performance and productivity in research, drug discovery, pre-clinical and clinical development, and bioprocess applications. Our low to mid-scale peptide synthesizer platforms are the new PurePep® Chorus, Symphony® X, and Sonata® XT. These solutions and our chemistries deliver uncompromising purity, flexibility, and quality synthesis for discovery and pre-clinical studies of simple to complex multifunctional peptides. Proprietary high performance nanoliter-scale immunoassay platforms, Gyrolab® xPand, Gyrolab xP workstation and Gyrolab xPlore™, and Gyrolab immunoassay kits are used by scientists at leading pharmaceutical, biotech, CRO, and CMO companies in the development and manufacturing of various biotherapies including those based on peptides, antibodies, and gene therapies and vaccines. Gyrolab immunoassays provide key workflow advantages of speed, automation, and low reagent usage, and assay quality advantages of wide dynamic range with robust precision and reproducibility in applications including pharmacokinetics/pharmacodynamics, immunogenicity, and analysis of bioprocess-related impurities. Our peptide synthesis and bioanalytical solutions accelerate the discovery, development, and manufacturing of safer biotherapeutics. Gyros Protein Technologies is part of the biopharmaceutical development division of Mesa Laboratories Inc (Nasdaq: MLAB).
This release contains “forward-looking statements” – that is, statements that relate to future, not past, events. In this context, forward-looking statements often address our expected future business and financial performance and financial condition, and often contain words such as “expect,” “assume,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “see,” or “will.” Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. These risks and uncertainties include the duration and severity of the COVID-19 pandemic, expectations regarding our products, our ability to develop and market new or improved products, our ability to compete effectively, international legal and regulatory risks, and product quality and liability issues. For further information regarding our risks and uncertainties, please refer to the “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operation” in Mesa Laboratories, Inc.’s public reports filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. We caution you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.