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 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.
Flatman
Stephen
S
Lonza Biologics Plc, 228 Bath Road, Slough, Berkshire SL1 4DX, UK. Steve.Flatman@lonza.com
Alam
Imtiaz
I
Gerard
Jeffery
J
Mussa
Nesredin
N
D000818:Animals; D000911:Antibodies, Monoclonal / Q000737:chemistry / Q000302:isolation & purification*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004586:Electrophoresis / Q000379:methods; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006801:Humans
D000911:Antibodies, Monoclonal