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dPCR Validation Standard CHO (Illustration similar or symbolic)
Illustration similar or symbolic

dPCR Validation Standard CHO

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

Cat. No.: 58-0211

€657.00
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Product Description

CHO cells are among the most important production cell lines for recombinant biopharmaceuticals, particularly monoclonal antibodies and therapeutic proteins. Residual CHO DNA remaining from the manufacturing process is considered a process-related impurity, and both its removal and residual concentration must be controlled. The dPCR Validation Standard CHO supports the product-specific evaluation of the dPCR method and enables monitoring of DNA clearance across different process and purification steps.

The dPCR Validation Standard CHO contains quantified genomic DNA from CHO cells to support NAT-based residual host-cell DNA determination. Serial dilution can be used to generate a CHO-specific standard curve and determine a matrix-specific conversion factor for converting dPCR results from [copies/µl] to [fg/µl], thereby supporting residual DNA quantification in accordance with regulatory guidelines.

Specification

Product category Residual DNA Standards
Species Chinese Hamster Ovary
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 CHO – 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.