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 bioreactors 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.
Process characterization is an important step in the overall journey of product development. In this poster, scientists propose a step-wise approach for the definition and execution of process characterization for the production of a monoclonal antibody.
Shortening timelines to generate more productive, stable, and high expressing cell lines is the goal of any cell line development program. This technical poster details the methodologies and clonal variation of combining a cell line development technology with a platform for clonal cell line selection.
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.