Rigorous detection of human residues is a key component of maintaining the safety, efficacy, and quality of biopharmaceutical products. This kit is based on fluorescence quantitative PCR technology and is designed with primers and probes targeting the conserved sequences of the human host cell genome. It is paired with a ready-to-use Human DNA quantitative reference, providing a rapid and highly sensitive real-time fluorescence quantitative PCR solution. This kit is used for the quantification of residual human host cell DNA in intermediates, semi-finished products, and final products of various biopharmaceuticals.
The kit can be used in conjunction with Biori nucleic acid extraction or purification kits, enabling detection of human host cell DNA at femtogram levels within as fast 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-QN54-100 说明书
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