BioSC® in a Fully Integrated Continuous MAb Manufacturing Process

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With the demand of higher production and reducing cost in biological manufacturing, continuous bioprocessing is replacing the traditional batch-mode manufacturing. Many biopharmaceutical companies are seeing the benefits of continuous processing. Novasep has enabled fully integrated continuous bioprocessing — from perfusion bioreactor to formulation.

Objective
This application note highlights a study conducted with Novasep’s BioSC Lab® technology for a fully continuous monoclonal antibody (MAb) production. BioSC Lab® is a sequential multicolumn chromatography (SMCC) system integrated as the capture step using protein A resin. BioSC® technology enables processes to run at higher linear flow rates while effectively using almost 100% of the capacity of a resin. The end result is a significantly improved productivity (gram of protein per liter of stationary phase per day), as well as significant reduction in buffer consumption (liters of buffer per gram of protein). Because of the increased productivity, the requirement of the stationary phase is significantly reduced, and only several small columns and small buffer vessels will be needed for scale up.

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