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Downstream Processing in Biotechnology: Essential Steps for Purification of Biologics

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Purification of Biopharmaceuticals

Downstream processes play a vital role in the manufacturing of therapeutic proteins and antibodies. Once the target protein has been expressed in a bioreactor, it must be purified to ensure product quality and safety. Common downstream purification techniques include:

Clarification and Chromatography

The first step in Downstream Processing is clarification to remove cell debris and other insoluble Matter. Methods like centrifugation or microfiltration are used to separate the biomass from the fermentation broth containing the target protein.

The clarified broth is then subjected to chromatography which utilizes differences in a molecule's interactions with a stationary and mobile phase to separate components. Affinity chromatography selectively binds the target protein based on its affinity for a ligand immobilized on the column. Ion exchange chromatography separates molecules based on surface charge, while size-exclusion chromatography separates based on molecular size.

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