Purification of a domain antibody (dAb) in a chromatography capture step was successfully scaled from laboratory to pilot scale using ready-to-use equipment and ready-made buffers. The scaled-up process shows reproducible results over triplicate runs, indicating process robustness. Results from the scaled-up process were comparable with the process run at laboratory scale. In addition, process economy of using ready-to-use equipment and ready-made buffers versus using reusable equipment and in-house prepared buffers was compared. A three-step dAb purification process was used as model. The results show that although operating expenses can be more extensive when scale and number of batches increase, ready-to-use equipment and ready-made buffers offer great time-savings. As less time is spent on equipment qualification and maintenance with these products, annual process time can be reduced by 3000 work hours, corresponding to two full-time equivalents (FTEs) per year by using ready-to-use equipment and ready-made buffers.
October 29, 2016