Process analytics for purification of monoclonal antibodies

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 inc...

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Published inJournal of chromatography. B, Analytical technologies in the biomedical and life sciences Vol. 848; no. 1; pp. 79 - 87
Main Authors Flatman, Stephen, Alam, Imtiaz, Gerard, Jeffery, Mussa, Nesredin
Format Journal Article
LanguageEnglish
Published Netherlands Elsevier B.V 15.03.2007
Subjects
Analytical methods
Animals
Antibodies
Antibodies, Monoclonal - chemistry
Antibodies, Monoclonal - isolation & purification
Chromatography, High Pressure Liquid - methods
Electrophoresis - methods
Enzyme-Linked Immunosorbent Assay - methods
Humans
Process analytical technology
Purification
Process analytical technology
Antibodies
Analytical methods
Purification
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Summary: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.
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-3
content type line 23
ObjectType-Review-1
ISSN:1570-0232
1873-376X
DOI:10.1016/j.jchromb.2006.11.018