Scale-up of monoclonal antibody purification processes |
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Authors: | Aldington Suzanne Bonnerjea Julian |
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Institution: | Lonza Biologics, Purification Development, 228 Bath Road, Slough, Berkshire SL1 4DX, UK. |
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Abstract: | 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. |
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