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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.

AAV Genome Titer and Genome Integrity

The AAV 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 GFP, CMV enhancer, CMV promoter, SV40 and customer’s gene of interest

Key Features

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Dynamic range 3E+9 - 3E+12 vg/mL

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Titer precision, CV 3-9%

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8 sample in 35 minutes

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System dependent automated assay of 8,16 and 32 samples

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Capable of strand specific titer

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Capable of genome integrity assessment

AAV Capsid Titer of Multiple Serotype

Quantitation of total capsids is one of the CQA monitored during each stage of AAV manufacturing. Gator Bio has developed a unique solution.
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Uses CaptureSelect AAVX nanobody probe

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Quantitate AAV1-10 serotypes

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Accurate with wide dynamic range

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Fast

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Plug-n-play

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Robust to various matrix used in process development and manufacturing

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Cost effective with reusable probes

Webinars

Strategies for Accurate, Easy and Fast Quantitation of AAV Serotypes

Accurate High Sensitivity AAV Quantitation and Empty/Full Ratio Determination

Webinar - Evaluation of Bio Layer Interferometry (BLI) for AAV kinetics measurements

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