E.coli Residual DNA Detection Kit

Escherichia coli (E. coli) has been widely used as a host system for the production of recombinant proteins for human therapeutic use. Among the impurities that need to be removed in downstream processing, residual host cell DNA poses a major safety concern. As a result, the World Health Organization (WHO) and national drug regulatory authorities generally permit no more than 10 ng of residual DNA per dose in biological products.

This kit is based on quantitative real-time PCR technology, with primers and probes designed to target conserved sequences in the E. coli genome. Combined with a ready-to-use E. coli DNA reference standard, this kit provides a rapid, highly sensitive solution for detecting and quantifying residual E. coli host cell DNA in various biological products, intermediates, semi-finished, and finished products. When used with Biori’s nucleic acid extraction or purification kits, the detection of E. coli DNA residues at fg levels can be completed in as little as 1.5 hours.

* The kit has undergone comprehensive methodological validation based on relevant regulations and guidelines. The performance validation report is available upon request.

Product Features:

• BP-QN24-100 说明书

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