Invention Grant
US08212207B2 Method of detecting filter extractables in biopharmaceutical products by liquid chromatography-mass spectrometry
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通过液相色谱 - 质谱法检测生物制药产品中过滤提取物的方法
- Patent Title: Method of detecting filter extractables in biopharmaceutical products by liquid chromatography-mass spectrometry
- Patent Title (中): 通过液相色谱 - 质谱法检测生物制药产品中过滤提取物的方法
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Application No.: US12674874Application Date: 2008-08-22
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Publication No.: US08212207B2Publication Date: 2012-07-03
- Inventor: Tongbo Jiang , Cheryl Follo , Maurice G. Phelan
- Applicant: Tongbo Jiang , Cheryl Follo , Maurice G. Phelan
- Applicant Address: US MA Billerica
- Assignee: EMD Millipore Corporation
- Current Assignee: EMD Millipore Corporation
- Current Assignee Address: US MA Billerica
- Agency: Hamilton, Brook, Smith & Reynolds, P.C.
- International Application: PCT/US2008/010026 WO 20080822
- International Announcement: WO2009/029231 WO 20090305
- Main IPC: H01J49/00
- IPC: H01J49/00 ; B01D59/44

Abstract:
The invention uses liquid chromatography-mass spectrometry to verify the presence or absence of the extractables introduced into a biopharmaceutical product during manufacture, filtration or storage at above a certain concentration. The method disclosed herein can be used to detect the presence of extractables in the actual biopharmaceutical product rather than a surrogate solvent system. Detection of the extractables in the actual drug product provides an accurate description of the leachables profile likely to be introduced to the human or animal patient. In one embodiment, the extractable are introduced by filtration of the bio-pharmaceutical product.
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