Scale-up of monoclonal antibody purification processes.
Mammalian cell culture technology has improved so rapidly over the last few years that it is now commonplace to produce multi-kilogram quantities of therapeutic monoclonal antibodies in a single batch. Purification processes need to be scaled-up to match the improved upstream productivity. In this chapter key practical issues and approaches to the scale-up of monoclonal antibody purification processes are discussed. Specific purification operations are addressed including buffer preparation, chromatography column sizing, aggregate removal, filtration and volume handling with examples given.
Aldington
Suzanne
S
Lonza Biologics, Purification Development, 228 Bath Road, Slough, Berkshire SL1 4DX, UK.
Bonnerjea
Julian
J
D000818:Animals; D000911:Antibodies, Monoclonal / Q000096:biosynthesis / Q000737:chemistry / Q000302:isolation & purification*; D018929:Cell Culture Techniques / Q000379:methods; D006801:Humans; D015202:Protein Engineering / Q000379:methods*
D000911:Antibodies, Monoclonal