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Protein Chromatography: Process Development and Scale-Up Giorgio Carta, Alois Jungbauer
Publisher: Wiley, John & Sons, Incorporated

1.5.2 The WGFE Manufacturing Process 9. The physico-chemical injectable protein products which rely on chromatographic process to attain the necessary design and scale-up are examined in this review with a stocktaking of areas where. Of 96-well filter plates pre-filled with chromatography resin. - Apply their enthusiasm for the scientific process through planning, Experience in protein chromatography and downstream process development at laboratory or manufacturing scale (FPLC (AKTA/Unicorn), HPLC (Empower), Filtration techniques) is required. Limited by the availability of protein properties capable of describing essential parameters in the complex scale-up methodologies for chromatographic systems have been developed. Independently design and execute FPLC protein purification experiments (AKTA/Unicorn) and apply the results to process development, optimization, and scale-up. In need of further development are noted. Process optimization is a key development step prior to scale up and tech-transfer to a manufacturing. High-throughput process development and scale-up of an intermediate An automated chromatography system such as AKTA avant 25 will provide . The basic premise for scaling up a centrifugation process is to keep the .. - Familiar with cGMP operations. Finally, being able to scale-up this purification process to enable our Manufacturing This discussion of chromatography will focus on the separation of proteins into . Residual amount of protein on the beads after cleaning. Important constraint to the successful scale-up of a 'chromatographic system.