A key component of bringing life saving cell and gene therapies to market is the production of viral vectors used to deliver the therapeutic gene. However, this requires efficient and scalable manufacturing strategies, which currently are one of the biggest barriers to commercialization of CGT products. One area where improvement is needed is analytical testing methods. These methods are used to determine the safety, strength, and purity of viral vectors.
Droplet digital polymerase chain reaction (ddPCR) is technique for determine AAV vector genome titer as well as to quantify residual host cell and plasmid DNA. It provides both accurate and precise results. Even though the dynamic range is not as large as qPCR, you can design the dilutions such that at least one dilution falls within the assay range.
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