HEK293 Residual DNA Detection Kit

The HEK293 human cell line has become a widely used expression vector in cell therapy, gene therapy, and biopharmaceuticals. It is extensively employed in the production of proteins, vaccines, anti-cancer reagents, and recombinant adenovirus vectors. However, the stability of host cell DNA can result in residual host cell DNA in biological products, which poses potential oncogenic and infectious risks. Therefore, it is crucial to ensure that host nucleic acid residues are kept within safe and controllable levels. Furthermore, regulatory bodies such as the Chinese Pharmacopoeia, European Pharmacopoeia, FDA, and WHO have established specific requirements for the content of residual host cell DNA.

This kit utilizes a fluorescence quantitative PCR method, designed with primers and probes targeting the conserved sequences of the HEK293 genome. Coupled with a ready-to-use HEK293 DNA quantitative reference, it provides a rapid, highly sensitive real-time quantitative PCR solution. This kit is intended for the quantification of HEK293 host cell DNA in intermediates, semi-finished products, and final products during the development of gene therapies, cell vaccines, and similar biotherapeutic drugs.

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

Product Features:

• BP-QN09-100 说明书

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