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

New - Biopharma Quality Control : Residual Host DNA Testing

Residual Host Cell DNA Testing

 

Detection of residual host cell DNA by dPCR with MiQuant® Residual DNA E. coli, CHO or HEK-293 - dPCR Kits.


  • Novel rapid, robust and sensitive method
  • Fast workflow as no sample preparation is required prior to PCR analysis
  • Meets EP, WHO and FDA criteria
  • Compatible with QIAcuity®, ddPCR™, Quantstudio™ Absolute Q™
  • Lyophilized kit components simplify logistics and storage

Residual host cell DNA testing is a critical aspect of quality control in the production of biopharmaceuticals, including recombinant proteins, monoclonal antibodies, and cell-based therapies. Host cell DNA refers to the genetic material originating from the cell line used to produce the biopharmaceutical product. For this purpose, CHO, HEK-293 and E. coli cells are frequently used. Even after extensive downstream purification processes, trace amounts of residual host cell DNA may remain in the final product, posing potential safety and regulatory concerns.

The WHO, FDA, and the European Pharmacopoeia recommend that the residual DNA concentration is less than 10 ng/dose in the final product.

Minerva Biolabs has developed a digital PCR assay for the detection of residual host cell DNA for E.coli, CHO or HEK-293 - MiQuant® Residual DNA dPCR. The use of dPCR reduces time-to-result since no sample preparation is required prior to dPCR analysis and enables absolute quantification without a standard curve. With the help of the dPCR Validation Standards it is possible to determine a matrix-specific conversion factor that converts [copies/µl] into [pg/µl] to provide a quantification of the residual DNA in conformity to regulatory guidelines.

Short multicopy targets in the CHO (repeated element, ~ 1 million copies per genome), E. coli (7 genome copies), and HEK-293 (repeated element, ~ 1 million copies per genome) genomes are amplified. The length of the amplicons is < 200 bp and, therefore, short enough to allow the amplification of highly degraded DNA according to guidelines.

MiQuant® Residual DNA dPCR HEK-293

The MiQuant® Residual DNA dPCR HEK-293 is designed for the quantitative detection of residual DNA from HEK-293 cells in chemical and biological matrices. The MiQuant® Residual DNA dPCR HEK-293 is designed for use with the QIAGEN® QIAcuity® digital PCR (dPCR) system as a novel rapid, robust and sensitive method for the detection of residual host cell DNA.

Minerva Biolabs

Catalogue No.DescriptionPack SizePriceQty
58-0121MiQuant® Residual DNA dPCR HEK-29324 reactions £426.00 Quantity Add to Order
58-0122MiQuant® Residual DNA dPCR HEK-2934x 24 reactions POA Quantity Add to Order

Description

The MiQuant® Residual DNA dPCR HEK-293 is designed for the quantitative detection of residual DNA from HEK-293 cells in chemical and biological matrices.


The MiQuant® Residual DNA dPCR HEK-293 is designed for use with the QIAGEN® QIAcuity® digital PCR (dPCR) system as a novel rapid, robust and sensitive method for the detection of residual host cell DNA.

Type of PCR
Digital PCR (dPCR)

Recommended Use
To test product quality, the amount of residual DNA in a drug's final dosage form must follow guidelines established by the World Health Organization (WHO), the U.S. Food and Drug Administration (FDA), the European Pharmacopoeia, and other regulatory agencies.

 

 

Flyer


Kit Components
    dPCR HEK-293 Mix in aliquots of 24 reactions each
    Rehydration Buffer
    Positive Control DNA
    Internal Control DNA
    dPCR Grade Water

Package Size
Cat. No. 58-0121:
24 reactions

Cat. No. 58-0122:
4 x 24 reactions

Result Evaluation
Absolute Quantification

Required Consumables
    PCR reaction tubes
    PCR Clean™ (15-2025, 15-2001)
    PCR reaction tubes or plates
    MiQuant® dPCR Validation Standard HEK-293 (Cat. No. 58-0221)

Required Lab Device
    QIAcuity® digital PCR cycle
    QIAcuity® 24Well 26K Nanoplates
    Microcentrifuge for PCR reaction tubes
    Pipetting equipment

Shelf Life and Storage
The expiry date of the unopened package is marked on the package label. The kit components must be stored at 2 to 8°C until use. The rehydrated components must be store at ≤ -18°C for a maximum of one month.

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