Recovery and purification process development for monoclonal antibody production.
Hundreds of therapeutic monoclonal antibodies (mAbs) are currently in development, and many companies have multiple antibodies in their pipelines. Current methodology used in recovery processes for these molecules are reviewed here. Basic unit operations such as harvest, Protein A affinity chromatography, and additional polishing steps are surveyed. Alternative processes such as flocculation, precipitation, and membrane chromatography are discussed. We also cover platform approaches to purification methods development, use of high throughput screening methods, and offer a view on future developments in purification methodology as applied to mAbs.
Liu
Hui F
HF
Oceanside Process Research & Development, Genentech, Inc., Oceanside, CA, USA. liu.hui@gene.com
Ma
Junfen
J
Winter
Charles
C
Bayer
Robert
R
D000818:Animals; D000911:Antibodies, Monoclonal / Q000096:biosynthesis* / Q000302:isolation & purification*; D016466:CHO Cells; D002845:Chromatography / Q000379:methods; D006224:Cricetinae; D003412:Cricetulus; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000379:methods*
D000911:Antibodies, Monoclonal