Transcription of Chapter 11 Downstream Processing - Biomanufacturing
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Chapter 11 Downstream Processing - Biomanufacturing
2016 Montgomery County Community College Chapter 11 Downstream Processing 424 Chapter 11 - 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.
Drug production of a required purity and efficacy at reasonable cost per unit is the overall goal of the downstream purification process. There are, however, several additional factors to be considered in approaching this goal. For example, the operational goals evolve over the
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