QUANTITATIVE ANALYSIS AND MONITORING OF PROTEIN STRUCTURE BY SUBSTRACTIVE CHROMATOGRAPHY

摘要

2088360 9202815 PCTABS00010 Methods are provided for making real-time determinations of the concentration and for monitoring the structural profile of a target solute in a solution. Non-diffusion bound affinity chromatographic techniques are used to generate chromatograms having sharply defined breakthrough curves. Based on the difference between the sensed equilibrium concentration of the impurities which break through the matrix and the concentration of all solutes in the sample, the concentration of the target solute in a solution can be determined. Alternatively, a chromatogram representative of the structural profile of a protein in a sample comprising a mixture of structural variants may be produced using the method of the invention. The assays may be carried out in real-time so that production or purification of a valuable substance such as a pharmaceutical recombinant protein or the like can be monitored meaningfully.