Residual DNA E. coli Kit
For use in quality control / manufacturing process only.
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Unit of measure is "piece".
Residual DNA E. coli Kit material number and pack size: Material Number Pack Size 07728735001 1 kit -
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).
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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 12 months.