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Table 7 Summary of the validation of qPCR for CHO residual DNA

From: Development and Validation of Quantitative Real-Time PCR for the Detection of Residual CHO Host Cell DNA and Optimization of Sample Pretreatment Method in Biopharmaceutical Products

Results

Valid method range

3 fg/ul-300 pg/ul

Linearity

1.000

LOD

3 fg/ul

LOQ

0.3 pg/reaction

Accuracy

82.3–105.7%

Precision

Repeatability(intra-precision)

0.065–0.452%

Inter- precision

0.471–1.312%