In the development of a monoclonal antibody process, new innovations are often driven by manufacturing facility constraints and the desire to provide simple, low-cost solutions that enable flexibility in operations.  One common manufacturing constraint across all production facilities is the size of the intermediate pool vessels, and their associated working volume limitations.  The harvest operation typically results in the largest pool volume of the entire downstream process, and therefore, there is a strong driver to perform an inline concentration to reduce the volume of the harvest material.  In this presentation, the evaluation of a tangential flow filtration method is discussed for use in this inline concentration application.  Membrane screening was performed using a flux excursion based approach, and a predictive model was generated to identify the appropriate operating parameters and filter sizing.  Considerations for maintaining sterility of the harvest material will be discussed, as well as an assessment of membrane fouling during harvest operations.  Results will be presented on the implementation of this operation, and the demonstrated success of achieving the desired concentration factors for the process.

Development of an inline concentration step for a continuous harvest process

247th National Meeting (2014)

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