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dPCR Validation Standard E. coli

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

Cat. no.: 58-0211

$899.00
Tax excluded

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Product Description

Escherichia coli (E. coli) is one of the most widely used and best-characterized host organisms for the production of recombinant biopharmaceuticals, particularly therapeutic proteins and antibody fragments. Residual E. coli host cell DNA remaining from the manufacturing process is considered a process-related impurity whose removal and residual concentration must be controlled. The dPCR Validation Standard E. coli supports product-specific evaluation of the dPCR method and enables monitoring of DNA clearance across different process and purification steps.

The dPCR Validation Standard E. coli contains quantified genomic DNA from E. coli to support NAT-based determination of residual host cell DNA. By serial dilution, an E. coli-specific standard curve can be generated and a matrix-specific conversion factor can be determined to convert dPCR results from [copies/µL] to [fg/µL]. This enables quantification of residual DNA in accordance with regulatory requirements.

Specification

Product category Residual DNA Standards
Species Escherichia coli
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 rehydration buffer
Detection method MiQuant® Residual DNA E. coli – 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.