Gyros Protein Technologies, a developer of automated nanolitre-scale immunoassays and a provider of peptide synthesisers and reagents, has announced the introduction of Gyrolab AAV9 Titer Kit for rapid determination of physical titre in adeno-associated virus serotype 9 (AAV9) vector-based cell and gene therapy manufacturing. The kit is based on a highly selective AAV9 affinity ligand developed with the CaptureSelect technology by Thermo Fisher Scientific. The ligands are also the basis of POROS CaptureSelect AAV9 Affinity Resin, used to purify AAV9 viral vectors.
The kit adds to the company’s existing range of ready-to-use products, increasing the its offering for analytical characterisation 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 can be used as a gene delivery vector owing to its ability to cross the blood-brain barrier and target the central nervous system with high efficiency. The kit supports improved development time and streamlined process transfer due to the standardised reagents and validated methods of the Gyrolab platform. The kit enables 96 data points to be generated in 80 minutes with the ability to handle small sample volumes, helping to reduce development timelines of novel biotherapeutics, including cell and gene therapies.
Mark Vossenaar, VP, General Manager, Gyros Protein Technologies, said: “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 characterisation during manufacturing and purification of cell and gene therapies. Physical titre determination is one of the key quality attributes of the FDA process validation guidelines and our new kit will enable researchers to maximise 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.”
