HEK293 Residual DNA Detection Kit (PCR-Fluorescence Probe Method)

Human cell line HEK293 has become a very common expression vector in cell therapy, gene therapy and biopharmaceuticals, and is widely used in the production of proteins, vaccines, anti-cancer reagents and recombinant adenovirus coatings, etc. Due to the stability of host cell DNA, it can lead to the residue of host cell DNA in biological products. Moreover, the residual DNA in biological products has potential tumorigenicity and infectivity. Therefore, it is necessary to ensure that the residual host nucleic acid is within a safe and controllable range. Meanwhile, the Chinese Pharmacopoeia, the European Pharmacopoeia, the FDA, and the WHO have respectively set corresponding requirements for the content of residual DNA in host cells.

This kit is based on the fluorescence quantitative PCR method. It designs primer probes for the conserved sequences of the HEK293 genome and pairs them with ready-to-use HEK293 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 HEK293 host cell DNA in intermediates, semi-finished products and finished products during the development process of gene therapy, cell vaccines and similar biological therapeutic drugs.

This kit, when used in conjunction with the Baorui Biological nucleic Acid extraction or Purification Kit, can detect FG-level HEK293 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-QN09-100

Product advantages

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