This application note demonstrates the use of Agilent's Mx3005P QPCR System and the resDNASEQ Quantitative CHO DNA Kit (Life Technologies) for the detection of residual CHO host cell DNA. This method produces more specific, more sensitive, and faster results than traditional blot hybridization methods.
This document describes a method for detecting residual Chinese Hamster Ovary (CHO) host cell DNA in therapeutic protein products using quantitative real-time PCR (qPCR). The study validates the use of the Agilent Mx3005P QPCR System with the resDNASEO Quantitative CHO DNA Kit. The results show that the system produces specific, sensitive, and rapid results, meeting FDA guidelines for residual DNA content.
The maximum acceptable amount is 100 pg per therapeutic dose.
These assays produce results in less than three hours.