METHOD OF DETECTING EXTRACTABLES IN BIOPHARMACEUTICAL PRODUCTS
摘要
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 biopharmaceutical product.
申请公布号
WO2009029231(A2)
申请公布日期
2009.03.05
申请号
WO2008US10026
申请日期
2008.08.22
申请人
MILLIPORE CORPORATION;JIANG, TONGBO;FOLLO, CHERYL;PHELAN, MAURICE, G.