近年来,利用宿主细胞系表达生物学产物的生物来源性药物的应用显著增加。 This has created a need to quantify residual host cell DNA during manufacturing and in final products.

Real-Time PCR Results

 

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.

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Precision Counts

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resDNASEQ Host Cell Residual DNA Quantitation System
  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

Step-by-Step Guide to Host Cell Residual DNA Quantitation Products

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Bacteria & Fungal Testing

Step-by-Step Guide to Host Cell Residual DNA Quantitation Products

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Bacteria & Fungal Testing

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