Consistent high quality monoclonal antibody yield is a key goal for cell culture bioprocessing. This endpoint is typically achieved in commercial settings through product and process engineering of bioreactor parameters during development. This presentation will provide an overview of CDER’s capabilities and regulatory research for the bioprocessing of monoclonal antibodies with a focus on bioreactor cell culture production, equipment and analytics.<br/><br/>This talk will also address the implementation of commercially available Process Analytical Technology (PAT) tools into our bioprocessing system to support real time predictive modeling of critical quality attributes. Thus, highlighting areas in which feedback loops with process controls can be supported in order to execute automated cell culture decisions.<br/><br/>The collaborative inter and intra agency regulatory research being conducted in these areas is utilized to support regulatory decision making and agency guidance documents.

Process analytical technology (PAT) for bioprocessing

251st National Meeting (2016)

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