resDNASEQ® Quantitative E. coli DNA Kit with PrepSEQ® Residual DNA Sample Preparation Kit

Catalog number: 4460366

Applied Biosystems™  Related applications: Contaminant & Impurity QC Testing | Microbial Protein Production

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Description

This quantitative PCR (qPCR)-based kit—part of the resDNASEQ® E. coliResidual DNA Quantitation System—enables highly sensitive quantitation of host cell DNA from E. coliexpression systems, typically in less than 4 hours.

The kit is part of an integrated system that includes sample preparation, TaqMan® Assay and master mix, standard DNA, instrument, and software. The system overcomes the limitations of traditional methods by combining high-recovery PrepSEQ® sample preparation and TaqMan® Assay-based quantitation of residual DNA.

Highly sensitive quantitation using proven TaqMan® real-time qPCR technology (Figure 1)
• Manual and automated sample preparation, optimized for quantitative recovery from complex sample matrices (Table 1)
• Consistent performance across the expected range of DNA fragment sizes (Figure 2)
• Integrated system from sample to results with sample preparation, master mix, TaqMan® primer/probe mix, and genomic DNA standard


Rapid, Sensitive Detection of E.Coli DNA
The resDNASEQ® E. coli Residual DNA Quantitation System is a quantitative PCR (qPCR)-based system for the detection of host cell DNA fromE. coli, an expression system commonly used for the production of recombinant proteins. Reliable and rapid, the system enables sensitive (LOQ = 15 pg DNA/ml test sample, Figure 1) and specific (Figures 2 and 3) quantitation ofE. coli DNA, typically in less than 4 hours. This performance helps ensure a high degree of confidence in quantitation data obtained from a broad range of sample types—from in-process samples to bulk drug substances—whether a sample contains high molecular weight or sheared DNA (Figure 3).

Table 1. DNA recovery using manual PrepSEQ® sample preparation protocol.

Assay performance data using 10 pg E. coli genomic DNA spike per sample, 3 analysts, and 9 test samples.

50 mg/ml protein sample
Mean Recovery Mean %CV
E. coli 83%5.04%


For Research Use Only. Not for use in diagnostics procedures.
For Research Use Only. Not for use in diagnostic procedures.

Specifications

Host Cell: E.coli
PCR Method: qPCR
Product Size: 100 reactions
Detection Method: Primer-Probe Detection
Isolation Technology: Magnetic Bead
Sample Type (Specific): Bulk Drug Substance Sample, Biopharmaceutical Purification Sample
High Throughput Compatibility: Automated Protocols, Not High Throughput-Compatible (Manual)

Contents & storage

Components of the resDNASEQ® Quantitative E. coli DNA Kit include:
• TaqMan® primer and probe mix
• TaqMan® master mix
• Host cell genomic DNA standard
• Negative control

Components of the PrepSEQ™ Residual DNA Sample Preparation
Kit include:
• PrepSEQ™ Core Nucleic Acic Extraction Kit
• PrepSEQ™ Residual DNA Module

Documents

Manuals & protocols