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Generally, protein purification entails five essential steps, i.e., extraction from biological matter, separation from lipids and nucleic acids (non-protein components), precipitation step, recovery of bulk protein from raw extract, utilization of hydrophobic or ion-exchange chromatography column for the separation of target protein from bulk protein, and more refined steps including affinity matrix to obtain highly refined target protein with high yields

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Consequently, 503(B) outsourcing facilities now have a 60-day grace period to discontinue their compounded versions of the drug

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