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dPCR Validation Standard HEK-293

Quantified genomic HEK-293 DNA to support the dPCR-based determination of residual host-cell DNA.
-Quantified gDNA from HEK-293 cells
-Supports method validation and process control
-Enables conversion of dPCR results from [copies/µl] to [fg/µl]

Cat. no.: 58-0221

$899.00
Tax excluded

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Manual.pdf
Flyer.pdf
SDS.pdf
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Product Description

HEK-293 cells are widely used in the production of viral vectors, such as AAV vectors, and recombinant proteins. HEK-293 DNA may remain in the final product as a process-related impurity and must therefore be reliably quantified during process development and quality control. The dPCR Validation Standard HEK-293 supports the product-specific evaluation of the dPCR method and the monitoring of DNA reduction throughout the downstream process.

The dPCR Validation Standard HEK-293 contains quantified genomic DNA from HEK-293 cells to support NAT-based host cell residual DNA quantification. Through serial dilution, a HEK-293-specific standard curve can be generated and a matrix-specific conversion factor determined to convert the dPCR results from [copies/µl] to [fg/µl], thereby enabling the quantification of residual DNA in accordance with regulatory guidelines.

Specification

Product category Residual DNA Standards
Species Human Embryonic Kidney
Sample type Purified genomic DNA
Application Determination of residual host-cell DNA
Application areas
  • Supports method validation and process control
  • Quantification of residual DNA
  • Determination of the conversion factor in fg/µl
Compliance EP 2.6.35, WHO, FDA
Contents
  • 1 vial containing 1 ng of lyophilized genomic DNA
  • 1 vial containing Tris buffer (10 mM TRIS-HCl, pH 8.5)
Detection method MiQuant® Residual DNA HEK-293 – dPCR
Required equipment
& consumables
  • PCR tubes, preferably low-bind and free of DNA and RNA
  • Centrifuge for 1.5 ml reaction tubes
  • Vortex mixer
  • Pipettes with corresponding filter tips
Concentration 1,000 pg/ml
Storage 2-8 °C; ≤ –18 °C after rehydration
Shipping Ambient temperature
Shelf life See expiration date on package

Regulatory Disclaimer

For research and industrial use only. Not for diagnostic or therapeutic use.