Bio-Rad Laboratories – Vericheck ddPCR™ Empty-Full Capsid Kit

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The rise of gene therapy has placed adeno-associated virus (AAV) vectors at the forefront of modern medicine, but with it comes a critical manufacturing challenge: accurately quantifying the ratio of empty to full capsids. This metric is essential for product safety and efficacy, as excess empty capsids can trigger immune responses without delivering therapeutic benefit. 

Traditional methods, such as analytical ultracentrifugation (AUC), transmission electron microscopy (TEM), or ELISA are labor-intensive, require large sample volumes, and often lack the precision needed for today’s fast-moving gene therapy market. Furthermore, these approaches often involve complex workflows, delayed turnaround times, and limited compatibility with crude lysates or low-concentration samples.

Optimizing AAV vector quantification with Droplet Digital PCR

Bio-Rad’s Vericheck ddPCR™ Empty-Full Capsid Kit represents a step-change in gene therapy research and production by delivering unmatched prevision, sensitivity and specificity, along with ease of use and high throughput capabilities for the accurate quantification of AAV genome titer, capsid titer, and empty-to-full ratio. Powered by Bio-Rad’s Droplet Digital™ PCR, this kit overcomes the limitations of traditional methods, offering:

• Absolute quantification without standard curves, overcoming variability and improving precision
• Simplified data analysis, simultaneously measuring genome titer, capsid titer, and empty-full capsid ratio
• High sensitivity with minimal sample input, requiring only 2 µL of lysate or purified AAV
• Fast turnaround, enabling up to 14 samples processed in less than a day
• Exceptional reproducibility (<2% CV) for critical quality attribute (CQA) assessment

Reliable capsid content measurements for major AAV serotypes

Unlike AUC, which relies on density-based separation and cannot distinguish between fragmented DNA or non-therapeutic content, Bio-Rad’s Vericheck ddPCR™ Empty-Full Capsid Kit directly quantifies functional payloads—ensuring that only quality-assured capsids progress in the workflow. Validated across major AAV serotypes (AAV2, AAV5, AAV8, AAV9), it enables seamless integration from research through to GMP manufacturing. This kit simultaneously provides consistent and reliable capsid content measurements across the AAV production process with high precision, multi-sample type compatibility, low-sample input, fast turnaround time, and easy data analysis.

By combining cutting-edge Droplet Digital PCR technology with a workflow-friendly, kit-based solution, Bio-Rad has delivered an innovation that accelerates gene therapy research and production With its cost-effective and accessible platform, the Vericheck ddPCR™ Empty-Full Capsid Kit represents a superior solution for modern gene therapy laboratories seeking to optimize their AAV vector processes.