Gator Bio has created unique solutions for several of the important quality aspects of AAV products used in gene therapy, and there is an ongoing research effort to expand these solutions. Gator Bio is the market’s sole solutions supplier that provides assays for genome titer and integrity, capsid titer, and empty-full ratio on a single automated platform.
AAV genome titer and genome integrity
The AAV genome titer and genome integrity assessment are crucial for guaranteeing effective therapy. While qPCR and ddPCR are widely employed for genome titer measurement, genome integrity is still a developing field.
Gator’s GeneSwift assays use extremely specific DNA hybridization, immunochemistry, and biolayer interferometry detection. They are rapid, easy, accurate, and precise, requiring little hands-on time.
Furthermore, this is the only assay on the market that can quickly titer both the positive and negative strands of the packaged genome.
A variety of kits are available for titer and integrity assessment, including assays for SV40, GFP, CMV enhancer, CMV promoter, and the customer’s gene of interest.
Key features
- System-dependent automated assay of 8,16, and 32 samples
- Dynamic range 3E+9 - 3E+12 vg/mL
- Titer precision, CV 3-9%
- Ability to assess genomic integrity
- Capable of strand-specific titers
- 8 samples in 35 minutes
Quantitation of multiple AAV serotypes
Image Credit: Gator Bio, Inc.
Total capsid quantification is a CQA monitored at each stage of AAV production. Gator Bio has created a unique solution.
- Uses the CaptureSelect AAVX nanobody probe
- Quantitate AAV1-10 serotypes
- Accurate with a broad dynamic range
- Fast
- Plug-n-play
- Reusable probes make it more affordable
- Robust to different matrixes used in process development and manufacturing
Source: Gator Bio, Inc.
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| Anti-PEG Probes |
AAVX Probes |
AAVX Probes |
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| AAV9 Probes |
AAV9 Probes |
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| High Sensitivity AAV Kit |
High Sensitivity AAV9 Kit |