Vector Copy Number Determination*
Determination of vector copy number (VCN) by digital PCR with MiQuant® CAR T Cell for general lentivirus-, CD19- or BCMA-specific target.
- In-Process Control and Release Testing
- Compatible with QIAcuity® dPCR platform
- Quantitation of VCN without standard curve
- For general Lentivirus- or CD19- or BCMA-specific target
- 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, safety, and consistency of these advanced medicinal products. VCN refers to the average copies of integrated lentiviral vectors per cell genome after ex vivo transduction of human or other mammalian cells.
By establishing robust methods for VCN determination, manufacturers can ensure the quality of cell therapies, optimize dosing regimens, and monitor long-term safety outcomes in patients. Moreover, regulatory agencies require comprehensive characterization of VCN as part of the product development and approval process to ensure patient safety and efficacy.
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. Different kit versions enable VCN determi-nation of lentivirus-, CD19- or BCMA-specific targets.
The kits are designed for the QIAcuity® dPCR platform from Qiagen. The use of digital PCR enables absolute quantitation of VCN without a standard curve.
Application Areas
VCN determination with the MiQuant® CAR T Cell kit is useful at different times. During the CAR-T cell production process it can be used as an in-process control to evaluate the transfection efficiency. As part of the QC release testing the VCN must be determined prior to administration to the patient. For long term monitoring of the therapy it is also possible to test blood samples of a patient treated with CAR-T cells. Besides these applications the MiQuant® CAR T Cell kits can also be used for determining VCN in cell culture samples in research and development.
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Find more information on MiQuant® CAR T Cell in our flyer.
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Beta testers wanted!
In connection with our product release of MiQuant® CAR T Cell, Minerva Biolabs is looking for suitable testers.
As a beta tester you will benefit from free test material and comprehensive technical support.
Please contact us at miquant@minerva-biolabs.com to give details on your test environment and to get further information.