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Host Cell Residual DNA Quantitation

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.

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

MycoSEQ® Mycoplasma Detection System
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

The PrepSEQ™ Residual DNA Sample Preparation Kit and protocols are optimized to enable highly efficient DNA recovery from typical biopharmaceutical purification process samples. Consistent performance has been demonstrated across a wide variety of complex test sample matrices. We have also verified recovery of CHO DNA spiked into the following matrices:

  • Acetate (20 mM) pH 3.5
  • Acetate (500 mM) pH 3.5
  • HCl (12 mM) pH 3.0
  • Glycine (20 mM) pH 2.0
  • Glycine (500 mM) pH 2.0
  • Acetate/NaCl (300 mM/0.5 M) pH 4.5
  • MES/NaCl (300 mM/0.5 M) pH 6.5
  • Bis (300 mM) pH 6.5; MES (300 mM) pH 6.0
  • Phosphate (300 mM) pH 5.0
  • Tris (50 mM) pH 8.0

Achieve efficiencies through automation
Automation of the sample preparation procedure on the MagMAX™
Express-96 Magnetic Particle Processor helps to increase throughput and
efficiency. Using the automated system, host cell residual DNA can be
isolated from up to 24 triplicate test samples, typically in less than 2 hours.

Prepare Samples Products

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Bioproduction Resources

Have questions about Gibco® media, POROS® chromatography resins, Applied Biosystems® SEQ rapid contaminant tests, or our Cell Therapy products?  Click below to access product brochures, training videos, mobile apps, and more.

  

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