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Residual DNA E.coli Kit

For use in quality control / manufacturing process only.

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Residual DNA E.coli Kit material number and pack size:
Material Number Pack Size
07728735001 1 kit
Unit of measure is "piece".
For the testing of cell culture samples for the absence of residual host cell DNA from E. coli bacteria.
The Roche Residual DNA E. coli Kit, based on proven real-time qPCR technology, makes testing of residual DNA from E. coli bacteria fast and reliable. It allows for high-confidence testing across a broad range of sample types, from in-process samples to bulk drug substance. The kit has a high sensitivity (LOD 1 pg/mL [10 fg/reaction]) and has been developed to meet WHO requirements. These characteristics are largely due to highly pure DNA-free buffers and enzymes supplied with the assay. An optimized sample preparation protocol for excellent DNA Recovery (min 80%) is available.
  • Ready-to-use reagents jump start your assay.
  • High Quality: Standardized manufacturing according to ISO 13485. Change notification also available.
The kit is used as a final drug release test to detect the amount of residual host cell DNA (E. coli).
Limit of Detection (LOD): 1 pg/mL
Limit of Quantification (LOQ): 5 pg/mL
Escherichia coli DNA is quantified using a real-time polymerase chain reaction (PCR) assay. The PCR-based assay is sensitive and specific for DNA from E. coli cells and not subject to detection of human or environmental DNA that might be introduced during sample handling.
Stability: At -15 to -25°C within specification range for 24 months.