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<b>New </b> - Biopharma Quality Control

New - Biopharma Quality Control : Vector Copy Number Determination

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

MiQuant® SP Beads

The MiQuant® SP Beads kit is a magnetic bead-based extraction kit and is intended for the isolation of nucleic acids from transduced cells for cell and gene therapy applications (e.g. CAR-T cell samples). A two-step binding mechanism allows to remove impurities in the sample matrix in combination with washing steps. Nucleic acids are eluted from the magnetic beads using an elution buffer. Extraction process can be done manually or automatically (e.g. with KingFisher™ Flex).

Minerva Biolabs

Catalogue No.DescriptionPack SizePriceQty
56-4010MiQuant® SP Beads10 extractions £111.00 Quantity Add to Order
56-4100MiQuant® SP Beads100 extractions £430.00 Quantity Add to Order

Description

MiQuant® SP Beads

The MiQuant® SP Beads kit is a magnetic bead-based extraction kit and is intended for the isolation of nucleic acids from transduced cells for cell and gene therapy applications (e.g. CAR-T cell samples). A two-step binding mechanism allows to remove impurities in the sample matrix in combination with washing steps. Nucleic acids are eluted from the magnetic beads using an elution buffer. Extraction process can be done manually or automatically (e.g. with KingFisher™ Flex).

The MiQuant® SP Beads kit with its fast performance and high extraction efficiency is adapted to our products of the MiQuant® series, such as MiQuant® CAR-T Cell dPCR kits.

Recommended Use

For the isolation of nucleic acids from transduced cells

  • CAR-T cell samples
  • Viral vector samples
Kit Components
  • Binding, Elution, Lysis, Rehydration and Wash Buffers
  • Magnetic Bead Suspension
  • Proteinase K
Package Size

Cat. No. 56-4010: 10 extractions

Cat. No. 56-4100: 100 extractions

Required Consumables
  • 1-propanol, ≥ 99,5 %, p.a.
  • 1.5 ml or 2 ml RNase-free reaction tubes (preferably low-bind)
Required Lab Device
  • Magnetic rack
  • Thermoshaker
  • Vortex mixer
  • Optional: Automated extraction device (e.g. KingFisher™ Flex) with corresponding DNase- and RNase-free plastic ware
 
Shelf Life and Storage

Shipment and storage at ambient temperature. Proteinase K has to be stored at 4 °C. The expiry date of the unopened package is marked on the package label.

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