gene therapy
Bioanalytical tools for AAV characterization in Gene Therapy
One Platform Many Solutions
Gator Bio has developed novel solutions for some of the critical quality attributes of AAV products used in gene therapy and has an ongoing research program to expand the solutions. Gator Bio is the only solutions provider in the market that offers assays for genome titer and integrity, capsid titer, and empty-full ratio on a single automated platform.
Introducing Gator GeneSwift Assay Kits
Genome titer, the process of quantifying the number of genomes in a given volume, is a crucial step in various biological applications, particularly in gene therapy and vaccine development. Gator Bio has developed a novel GeneSwift titer assay that leverages DNA/RNA or nucleic acid hybridization, immunochemistry and biolayer interferometry technology (BLI)
Genome Titer and Genome Integrity
The genome titer and genome integrity assessment are critical to ensuring highly efficacious treatment. While qPCR and ddPCR are commonly used for genome titer determination, genome integrity is still an evolving field.
Gator’s GeneSwift assays combine highly specific DNA hybridization, immunochemistry and biolayer interferometry detection. The assay is fast, simple, accurate and precise needing minimal hands-on time. Also, this is the only assay on the market that can easily titer both the positive and negative strands of the packaged genome.
Multiple kits are offered for titer and integrity determination that include kits for EGFP, CMV enhancer, CMV promoter, SV40 and customer’s gene of interest
Key Features
8, 16, or 32 samples in 35 minutes (instrument dependent)
Dynamic range 4E+9 – 1E+12 vg/mL
No serial dilutions required
Titer precision, CV 2-12%
Capable of strand specific titer (ss or ds titer)
Capable of genome integrity assessment
AAV Capsid Titer of Multiple Serotypes
Quantitation of total capsids is one of the CQA monitored during each stage of AAV manufacturing. Gator Bio has developed a unique solution.
Uses CaptureSelect AAVX nanobody probe
Quantitate AAV1-10 serotypes
Accurate with wide dynamic range
Fast
Plug-n-play
Robust to various matrix used in process development and manufacturing
Cost effective with reusable probes
