The purification process of a drug lead eventually is transferred to a manufacturing scale production. The more efficient the process, the less expensive it is to make the drug. The purification conditions are optimized to increase yield and for cost efficiency. The transition from R&D to clinical trial requires an increase in scale. This and any future process change requires confirming that the molecule has not changed with respect to protein analytics.

Manufacturing scale affinity chromatography operates through equilibrium binding principles. DFC with PhyTip columns also operate through equilibrium binding and offer the only truly scalable small-volume tool available for process development.

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