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Residual DNA Quantitation

qPCR CHO Host Cell Quantitation.
Precision Counts.

The use of biologically derived drugs, in which host cell lines are used to express biological product, has increased dramatically in recent years. This has created a need to quantify residual host cell DNA during manufacturing and in final products.

To ensure product quality, the amount of residual DNA in a drug's final dosage form must meet regulatory guidelines established by the World Health Organization (WHO), the European Pharmacopeia, the US Food and Drug Administration (FDA), and other regulatory agencies.

Quantitate Residual DNA in Under 5 Hours
Keep quantitation in-house with the resDNASEQ™ CHO Residual DNA Quantitation System—the world's first integrated Real-Time qPCR system for quantitation of residual CHO host cell DNA. The system combines qPCR-based quantitation with magnetic bead-based sample preparation, which enables you to get precise DNA recovery from complex matrices. This helps you accelerate process characterization and execute rigorous process clearance studies.

  • Includes sample preparation, CHO quantitative standard DNA, TaqMan® assay, and master mix
  • Highly sensitive, specific quantitation
  • Optional automated sample preparation delivers up to 24 test results in 5 hours

 
Real-Time PCR Results
 
resDNASEQ™ CHO Residual DNA Quantitation System
 

Products & Other Resources

    System Workflow
    Where to Test for Residual DNA