The goal of this study was to understand the impact of monitoring osmolality during an Ultrafiltration/Diafiltration (UF/DF) step prior to CEX capture of the monoclonal antibody Rituximab. The process of UF/DF in downstream workflows is essential within the production of biological therapeutics, such as monoclonal antibodies, proteins (e.g. hormones) and nucleic acids. The UF/DF steps can be undertaken separately or in combination to prepare the target molecule, including sample cleanup, purification, concentration, buffer exchange, and desalting. Since both pH and conductivity are both standard metrics used in downstream process analytics, they were used as a base to then build a model around osmolality measurements within the process of UF/DF.
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