Cell and gene therapy
Cell and gene therapy with digital PCR – from research to bioprocessing & QC
How to ensure the quality and reproducibility of your therapeutic product
Quality control in cell and gene therapy
The system is coupled to a feature-rich QIAcuity Security Edition Software enabling labs to adhere to 21 CFR Part 11 compliance requirements in a GMP setting.
We also guarantee Installation Qualification (IQ) and annual Operational Qualification (OQ) services, 24/7 technical and scientific support and repairs performed by certified professionals ensuring you reliable quality control.
Cell and gene therapy workflows
Resources for gene therapy applications
Learn more about our products for gene therapy
Residual host-cell DNA (HCD) carryover poses major safety concerns when manufacturing protein and vaccine therapeutics. Risks include oncogenicity, infectivity and immunogenicity caused by your cell or gene therapy product. Therefore, levels of HCD must not exceed those established by regulatory agencies such as the U.S. Food and Drug Administration and the World Health Organization.
In comparison to qPCR, digital PCR provides higher sensitivity of detection at a lower template input range, enabling more robust applications. A multicopy target assay ensures that results are not affected by the fragmentation level of residual DNA (resDNA), a problem with qPCR.
Moreover, contaminating DNA in your PCR reagents can be a significant source of background and false positives. Ultra Clean Production enhances the specificity and efficiency of probe-based digital PCR to provide accurate, singleplex, or up to 5-plex analysis. Dedicated processes are implemented to enable Ultra Clean Production of the master mix, which minimizes contaminating DNA background and GC bias and gives you absolute certainty in your PCR reagents, making it an ideal choice for contamination-free, microbial applications as well as quality control applications, like residual DNA testing.
Find products for contaminant testing
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