发明申请
US20090325175A1 METHODs OF DETECTION AND QUANTIFICATION OF HOST CELL DNA CONTAMINATION OF PURIFIED PROTEINS 审中-公开
检测和定量纯化蛋白质细胞DNA污染的方法

METHODs OF DETECTION AND QUANTIFICATION OF HOST CELL DNA CONTAMINATION OF PURIFIED PROTEINS
摘要:
The present invention provides a novel robust, sensitive, reproducible, and accurate method of detecting and quantifying host cell genomic DNA contamination utilizing quantitative real time Polymerase Chain Reaction (qPCR), wherein the qPCR primers are complementary to the highly repetitive host cell genomic DNA sequences, e.g., Alu-equivalent sequences. The present invention is particularly useful for determining the levels of residual genomic DNA in biological products to be administered as therapeutics, e.g., therapeutic proteins.
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