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Host Cell Residual DNA Quantitation

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resDNASEQ™ Residual DNA Quantitation Systems

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.

The removal of host cell impurities is a critical step in the purification of biopharmaceutical products. A major challenge is the accurate and sensitive quantitation of host cell DNA impurities in both the purification process and in drug substance samples.

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.

A host cell quantitation system should be designed with the sensitivity to meet or exceed regulatory requirements, while enabling high throughput and cost effectiveness to enable robust process clearance study design.

Precision Counts
The Life Technologies resDNASEQ® Host Cell Residual DNA Quantitation Systems (Figure 1) measure levels of residual DNA from common host cell lines used in the production of biopharmaceutical products. The systems offer:

  • High-sensitivity quantitation using proven real-time qPCR technology
  • Specificity for target host cell DNA; no cross-reactivity with unrelated DNA
  • Consistent performance across the expected range of DNA fragment sizes
  • Accurate, reliable, and reproducible results
  • Optimized sample preparation for quantitative recovery from complex matrices
  • Option to automate sample preparation

Broadest panel of assays for the most commonly used cell lines for Monoclonal Antibody, Vaccine, and Recombinant Protein Production – CHO, E.coli. Vero, MDCK, NS0, Human, Pichia pastoris, Yeast

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