New kit enables researchers to generate more data in less time to support viral vector bioprocess analytics.
Uppsala, Sweden, 30 September 2021: 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® AAV9 Titer Kit for rapid determination of physical titer in adeno-associated virus serotype 9 (AAV9) vector-based cell and gene therapy manufacturing. The new Gyrolab AAV9 Titer Kit enables researchers to improve productivity and is based on a highly selective AAV9 affinity ligand developed with the Thermo Scientific™ CaptureSelect™ technology by Thermo Fisher Scientific. These ligands are also the basis of POROS™ CaptureSelect AAV9 Affinity Resin, which is frequently used to purify AAV9 viral vectors.
The new kit adds to the Company’s existing range of ready-to-use kits, increasing the Company’s offering for analytical characterization during manufacturing and purification of cell and gene therapies and complementing the Gyrolab AAVX Titer Kit, and the recently launched HEK 293 HCP Solution for Gyrolab (with reagents ordered from Cygnus Technologies). The AAV9 serotype is attractive as a gene delivery vector owing to its ability to cross the blood-brain barrier and target the central nervous system with high efficiency. With the industry’s focus on faster bench to bedside processes, the new kit supports improved development time and streamlined process transfer due to the standardized reagents and validated methods of the Gyrolab platform. The AAV9 Titer Kit provides fast results, enabling 96 data points to be generated in 80 minutes, an improved assay working range compared to ELISA methods, and the ability to handle small sample volumes (10x less compared to an ELISA), helping to reduce development timelines of novel biotherapeutics, including cell and gene therapies.
Mark Vossenaar, Vice President, General Manager, Gyros Protein Technologies, commented: “The addition of Gyrolab AAV9 Titer Kit to our portfolio of ready-to-use kits exemplifies our commitment to offering the whole range of tools required for analytical characterization during manufacturing and purification of cell and gene therapies. Physical titer determination is one of the key quality attributes of the FDA process validation guidelines and our new kit will enable researchers to maximize performance and productivity when developing therapies based on the AAV9 serotype, which will ultimately reduce the time needed to produce patient treatments.”
The Analytical Science team at Pharmaron Gene Therapy added: “We beta-tested the Gyrolab AAV9 Titer Kit and found excellent linearity and comparability with our commercial ELISA across a range of typical in-process samples. The broad dynamic range and small volume requirements will make it a valuable asset within our bioanalytical toolbox.”