Cellular and Gene Therapy Digital PCR Solution
Cell and gene therapy (CGT, Cellular and Gene Therapy) is a new field of cancer and genetic disease treatment, and it is also the most promising development direction in the field of biomedicine.
Quality control indicators such as genome copy number of gene therapy drugs, host cell genomic DNA residues, other production-related DNA residues (plasmid DNA or baculovirus genomic DNA), replicating virus residues, and mycoplasma must pass strict tests to ensure the safety of related products. safety and effectiveness. It has become an urgent problem to choose the appropriate technology to realize the detection of the above indicators.
Digital PCR, as the most sensitive and accurate direct quantitative tool among various nucleic acid detection technology platforms, is the best choice to complete this type of detection task.
“Digital PCR dilutes target nucleic acid molecules into a large number of droplet units. Each droplet contains one or more, or does not contain target DNA templates. The droplet units are independently amplified in parallel. After the amplification, the target molecule template is contained. The microdroplets will give a fluorescent signal, and finally according to the Poisson distribution principle and the proportion of positive microdroplets, the analysis software can calculate the concentration or copy number of the target molecule. Therefore, the absolute quantification of the target molecule can be performed without a standard curve. “
