Chapter 11 Downstream Processing - Biomanufacturing

Chapter 11 Downstream Processing 424 Downstream Processing Objectives This Chapter provides an overview of Downstream Processing . After completing this Chapter , students will be able to: describe the general elements of the Downstream purification process for a typical monoclonal antibody-based therapeutic, starting with the bioreactor harvest pool and finishing with pre-formulation, pure drug product. explain the overall goals of the purification process from the standpoint of purity, yield, and efficiency as well as the general strategies employed to achieve these goals. define the specific methods and in-process tools and materials used in typical steps of the Downstream process and the purposes and physical/chemical mechanisms occurring at each step, including: clarification of the bioreactor harvest by depth filtration and/or centrifugation capture chromatography for product concentration and initial purification ultrafiltration and diafiltration of the product at various stages in the Downstream process intermediate purification chromatography steps final polishing chroma

430 Downstream Processing Table 11-1: Commonly employed downstream processing methods (adapted from Kemp and O’Neil 2003) Processing Method Attributes Benefits Limitations Clarification: (often considered part of the upstream processing train) Sedimentation- based Clarification continuous centrifugation capable of handling very

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  Processing, Upstream, Downstream, Downstream processing

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