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Introduction of downstream processing: Downstream processing (DSP) refers to the series of operations that occur after the production or synthesis of a desired product in a biological system (like a cell culture or fermentation broth). Importance of downstream process: Product Quality: DSP removes impurities like cell debris, proteins, DNA, endotoxins, and other contaminants that could affect the safety and efficacy of the final product. Regulatory Compliance: Stringent regulatory standards require biopharmaceuticals and other biological products to be highly pure and well-characterized. DSP plays a critical role in meeting these standards. Commercialization: DSP transforms a crude mixture into a marketable product with the desired purity, concentration, and formulation. Steps in process: Solid-Liquid Separation. Product Isolation. Product Purification. Polishing. Formulation. Principles of downstream process: Downstream processing (DSP) is governed by several key prin...
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