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.

Ordering Information

Sku Name Size Price Qty
4413686 PrepSEQ® Residual DNA Sample Preparation Kit 100 preps USD 715.02
4457858 16-position Magnetic Stand 1 each ***
4456933 MagMAX™ Express-96 Deep Well Magnetic Particle Processor (PHARMA) 1 instrument Request a Quote  
4388487 MagMAX™ Express-96 Deep Well Tip Combs 100 pieces USD 522.00
4388476 MagMAX™ Express-96 Deep Well Plates 50 plates USD 310.00
4388475 MagMAX™ Express-96 Standard Plates 48 plates USD 153.00
4388435 MagMAX™ Express-96 Deep Well Magnetic Head 1 each USD 3,135.00

Next, combine the purified DNA template with the assay mix included in the resDNASEQ Residual DNA Quantitation System.

Ordering Information

Sku Name Size Price Qty
4413713 resDNASEQ™ Quantitative CHO DNA Kit, with protocol and quick reference card 100 reactions USD 2,461.00
4402085 resDNASEQ™ Quantitative CHO DNA Kit 100 reactions USD 2,081.00
4460366 resDNASEQ® Quantitative E. coli DNA Kit & PrepSEQ® Residual DNA Sample Preparation Kit 100 reactions USD 2,461.00
4458435 resDNASEQ® Quantitative E. coli DNA Kit 100 reactions USD 2,060.00
4460367 resDNASEQ® Quantitative Vero DNA Kit and PrepSEQ® Residual DNA Sample Preparation Kit 100 reactions USD 2,487.00
4458444 resDNASEQ® Quantitative Vero DNA Kit 100 reactions USD 2,157.00
4464335 resDNASEQ® Quantitative MDCK DNA Kit 100 reactions USD 2,157.00
4464336 resDNASEQ® Quantitative Pichia pastoris DNA Kit 100 reactions USD 2,157.00

The resDNASEQ® Host Cell Residual DNA Quantitation Kits exhibit a broad dynamic range and high sensitivity (Figure 2). The limit of quantitation (LOQ) of the assays is based on recovery and quantitation of standard genomic DNA recovered from a test sample matrix consisting of 50 mg/mL IgG. Typical results for these kits are:

  • CHO 1.5 pg/mL
  • Vero 1.5 pg/mL
  • NSO 1.5 pg/mL
  • E. coli 15 pg/mL
  • MDCK 1.5 pg/mL

Ordering Information

Sku Name Size Price Qty
4365464 7500 Fast Real-Time PCR System, laptop, QST 1 system Contact Us  

AccuSEQ™ Real-Time PCR Software is an intuitive easy-to-use analysis tool for data interpretation. The software guides the user through the experiment and plate setup and provides easy-to-use tools for defining and setting up standards, controls, and unknowns. AccuSEQ™ v2.0 software is designed for analysis of results obtained from ViralSEQ®, MycoSEQ™, resDNASEQ®, and ProteinSEQ™ kits.

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Learn more about AccuSEQ™ v2.0 analysis software

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