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
- 专利标题: METHODs OF DETECTION AND QUANTIFICATION OF HOST CELL DNA CONTAMINATION OF PURIFIED PROTEINS
- 专利标题(中): 检测和定量纯化蛋白质细胞DNA污染的方法
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申请号: US12476101申请日: 2009-06-01
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公开(公告)号: US20090325175A1公开(公告)日: 2009-12-31
- 发明人: Karin Anderson , Mark William Leonard , Denise Alice Fahey
- 申请人: Karin Anderson , Mark William Leonard , Denise Alice Fahey
- 申请人地址: US NJ MADISON
- 专利权人: WYETH
- 当前专利权人: WYETH
- 当前专利权人地址: US NJ MADISON
- 主分类号: C12Q1/68
- IPC分类号: C12Q1/68
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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