Developing effective and reproducible gene therapies while ensuring safety and effectiveness in patients is complex, and there is no room for error. Bio-Rad’s portfolio of Droplet Digital PCR (ddPCR) products for AAV Gene Therapy utilize the precision and sensitivity of ddPCR technology and work seamlessly with each other, offering a complete ddPCR workflow solution to check the quality of your therapeutic product.

AAV Viral Titer Workflow Solution

MOgene’s complete AAV Viral Titer Workflow Solution offers custom and ready-to-order ddPCR Assays. The solution is an optimized protocol to help you start-all reagents and consumables required for an end-to-end ddPCR workflow, instrument platforms-including the QX ONE ddPCR System, our flagship system expertly designed for Biopharma manufacturing, and software packages that enable regulatory compliance. When used together, these products deliver a precise and convenient solution to help you validate the quality of your therapeutic product with confidence.

Benefits of having a validated system for performing quality control on your samples

The ddPCR assay development system has been validated, so it is a faster, less costly alternative to send samples off for analysis with outside testing facilities. This system allows scientists to have GMP quality control on their samples without going through long protocols of sending out samples to outdoor testing facilities.

How to start working with a CRO (Contract Research Organization) for critical outsourcing projects

The benefit of having a validated system for performing quality control on your samples is that you’ll have more clarity and power over the results. Once you find out how to start working with a CRO for critical outsourcing projects, they can help take away some of the burdens while also providing expert guidance when needed.

With the recent advancements in ddPCR technology, scientists can now detect contaminants and assess viral titer metrics for gene therapies in less than a day. This may sound great, but there are some pitfalls to this method that are explained later on; first, let’s look at how ddPCR works.

What is ddPCR, and why does it matter for AAV GMP Quality Control?

Digital Droplet PCR Assay Development is a molecular biology technique that uses digital droplet technology. Digital Droplet PCR can be used to detect contaminants and assess viral titer metrics for gene therapies in less than a day, which may sound great, but there are some pitfalls to this method, as explained below. The benefits of the ddPCR are numerous, and the process can be performed in a semi-automated fashion. A ddPCR assay can detect contaminants with an accuracy of up to 99%. It also detects impurities that are not detectable by other methods and does so more precisely while still being cost-effective.

How to use the ddPCR assay development method

The top ways to use the ddPCR Assay Development method are as follows:

   – To assess AAV GMP quality control

   – For low viral titers for gene therapies such as HIV and influenza.

The ddPCR Assay Development is a molecular biology technique that uses digital droplet technology to detect contaminants in pharmaceuticals and biological fluids, or you can also use it for PCR.

The ddPCR Assay Development is a quicker and more precise method than other methods used in the industry to detect contaminants, such as BIO-RAD’s Bio-TiterTM Genotoxicity Assay, which takes around two days to complete.

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