Vector Copy Number Determination
Determination of vector copy number (VCN) by digital PCR with MiQuant® CAR-T Cell Lenti – dPCR.
- In-Process Control and Release Testing
- Compatible with different dPCR/ddPCR platforms
- Quantitation of VCN without standard curve
- Works with human or other mammalian cells
- Accurate and reproducible results
- Calculation of VCN with analysis software
- Lyophilized kit components simplify logistics and storage
The determination of vector copy number (VCN) in cell therapies is a critical step in assessing the potency and consistency of these advanced medicinal products. VCN refers to the average copies of integrated lentiviral vectors per cell genome after ex vivo transduction. To minimize the risk of insertional mutagenesis, the FDA recommends a VCN < 5.
The MiQuant® CAR-T Cell kits have been developed for the determination of VCN in transduced cells. After extracting genomic DNA, the copies of the lentiviral gene are determined in relation to the human housekeeping gene PCBP2 by digital PCR.
This kit provides a specific primer/probe mix and offers an open-platform solution for use with various dPCR devices (QIAcuity®, ddPCR™, Quantstudio™ Absolute Q™). The use of digital PCR enables absolute quantitation of VCN without a standard curve.
Application Areas
The MiQuant® CAR-T Cell kits can be used for VCN determination during the production process as an in-process control and prior to infusion into the patient as final QC release testing. Besides these applications the MiQuant® CAR-T Cell kits can also be used for determining VCN in cell culture samples in research and development.
Calculate the Vector Copy Number with our tool.
Data Analysis Application
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