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Residual DNA CHO Kit

For use in quality control / manufacturing process only.

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Order information
Residual DNA CHO Kit material number and pack size:
Material Number Pack Size
07427689001 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 CHO cells.
The Roche residual DNA CHO Assay, based on proven real-time qPCR technology, makes testing of residual DNA from the Chinese hamster ovary (CHO) cell line fast and reliable.  It allows for high-confidence testing across a broad range of sample types, from in-process samples to bulk drug substance.
  • Ready-to-use reagents jump start your assay.
  • High Quality: Standardized manufacturing according to ISO 13485."
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Application
The kit is used as a final drug release test to detect the amount of residual host cell DNA (CHO).
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Specification
The kit was developed to meet the sensitivity requirements defined by WHO (10 ng CHO DNA per therapeutic dose).
Linearity is demonstrated by analysis of CHO cell standard DNA ranging from 4 pg/mL to 400 ng/mL.
Chinese hamster ovary (CHO) DNA is quantified using a real-time polymerase chain reaction (PCR) assay. The PCR-based assay is sensitive and specific for DNA from the CHO cell line 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.