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 Pharmacopoeia, the US Food and Drug Administration (FDA), and other regulatory agencies.

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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.

The Applied Biosystems resDNASEQ™ host cell residual DNA quantitation systems measure levels of residual DNA from common host cell lines used in the production of biopharmaceutical products.


Features and Benefits:

  • PCR sensitivity: accurate quantitation down to 1.5 pg/mL of host cell DNA
  • Wide dynamic range: up to 6 logs of dynamic range
  • Robustness: dilution linearity and efficiency in complex matrices
  • Specificity: highly target DNA-specific with no cross reactivity to unrelated DNA

The software solution for residual DNA detection

The Applied Biosystems™ AccuSEQ™ Real-Time PCR Detection Software supports the unique needs of analytical testing of contaminants and impurities during the biopharmaceutical manufacturing process, as well as routine qPCR assays.

AccuSEQ software is part of the integrated workflow for Mycoplasma detection, residual Protein A quantitation, and residual DNA quantitation. Automated analysis tools enable one-click processing of complex Ct, amplitude (DV), and melting temperature for the MycoSEQ™ Mycoplasma detection assay according to user specifications. Nonlinear curve-fitting enables rapid analysis of ProteinSEQ Protein Quantitation System data. Next-generation algorithms deliver accurate quantitation data for the resDNASEQ™ Residual Host Cell DNA Quantitation.

Key features

  • Interfaces with the Applied Biosystems™ 7500 Fast Real-Time PCR instrument
  • Accurate quantitation of host cell residual DNA
  • Single software platform for multiple SEQ real-time PCR assays

Resources

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Datasheets

Protocols and quick reference cards

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Videos

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Applied Biosystems SEQ Analytical Solutions for Pharmaceutical manufacturing. Watch video ›

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Product and Process Impurities Analysis. Watch video ›

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