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Residual DNA E. coli Kit

For use in quality control / manufacturing process only.

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Order information
Residual DNA E. coli Kit material number and pack size:
Material Number Pack Size
07728735001 1 kit (96 reactions)
Unit of measure is "piece".
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Overview
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.
  • Fast Time-to-Result: < 5 hours
  • High Sensitivity Linearity from 10 µg/mL to 5 pg/mL
  • Lower Quantitation Limit: 5 pg/mL (50 fg/reaction)
  • Lower Detection Limit: 1 pg/mL (10 fg/reaction)
  • High Specificity: No cross-reactivity with unrelated DNA.
  • Robust: Suitable for different matrices from in-process samples to bulk drug substances.
  • Manual sample prep with optimized protocol for excellent DNA Recovery (min 80%) and real-time PCR.
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Application
The kit is used as a final drug release test to detect the amount of residual host cell DNA (E. coli).
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Specification
  • Sample Prep Manual Protocol (using MycoTOOL Prep Kit)
  • All Reagents Included: Supplied and ready-to-use reagents jump start your assay.
  • High Quality: Standardized manufacturing according to ISO 13485. Change notification also available.