The number of more complex biopharmaceuticals in development continues to increase and some of these include molecules that require multiple proteins to be expressed at differing ratios to produce the correct biopharmaceutical. In this article, the authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
The 3M Emphaze AEX Hybrid Purifier is a novel purification tool that utilizes a Q-functional hydrogel and 0.2 µm membrane to reduce impurities in a biopharmaceutical downstream process. This study involved a design of experiment (DoE) approach to investigate the effects of pH and conductivity on the turbidity, yield, and impurity clearance of the Emphaze AEX Hybrid Purifier and the efficiency of the subsequent protein capture step.
Current continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed-batch and perfusion bioreactor unit processes are relatively mature, downstream process unit operations are less mature. In this case study, the productivity of purifications running in batch versus continuous mode are compared.