E.coli Residual DNA Detection Kit (PCR-Fluorescence Probe Method)

Escherichia coli has been widely used as a host system to produce recombinant proteins for human treatment. Among the impurities that need to be removed in the downstream process, the residual host cell DNA is the main issue for safety. Therefore, the WHO and drug registration regulatory authorities of various countries generally only allow residual DNA of less than 10ng per dose to exist in biological preparations.

This kit is based on the fluorescence quantitative PCR method. It designs primer probes for the conserved sequences of the E.coli genome and pairs them with ready-to-use E.coli DNA quantitative reference materials to establish a rapid detection and highly sensitive real-time fluorescence quantitative PCR kit. It is used for the quantitative detection of E.coli host cell DNA in intermediate products, semi-finished products and finished products of various biological products and drugs.

This kit, when used in conjunction with the Baorui Biological nucleic Acid extraction or Purification Kit, can detect FG-level E.coli DNA residues in as fast as 1.5 hours.

This kit has undergone comprehensive methodological validation in accordance with relevant regulations, guidelines and other document requirements, and can provide performance validation reports.

Product item Number: BP-QN24-100

Product advantages

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