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文件名称:微生物Process analytics for purification of monoclonal antibodies
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The application of appropriate analytical methods is an essential requirement for the purification of therapeutic antibodies. A range of analytical
methods need to be employed to effectively determine the purity, identity, integrity and activity of these important class of pharmaceuticals. These
include notably electrophoresis, high performance liquid chromatography and immunoassays. Regulatory and industry demands in recent years
have brought the need for improvements and many have been successfully implemented. This article reviews the current analytical methods applied
to support the purification of monoclonal antibodies
methods need to be employed to effectively determine the purity, identity, integrity and activity of these important class of pharmaceuticals. These
include notably electrophoresis, high performance liquid chromatography and immunoassays. Regulatory and industry demands in recent years
have brought the need for improvements and many have been successfully implemented. This article reviews the current analytical methods applied
to support the purification of monoclonal antibodies
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