Procedure to monitor, evaluate and control a cyclic chromatographic purification procedure

摘要

Procedure to monitor, evaluate and control a cyclic chromatographic purification procedure that involves, at least, two adsorbents, through which a liquid passes with a feed mixture (Feed), which comprises the components of the desired product (P) , as well as impurities (W, S), said purification procedure comprising at least two different phases (I, B), at least one interconnected phase (I), in which the two adsorbents are interconnected so that the The outlet of an upstream adsorbent is fluidly connected to the inlet of a downstream adsorbent, and at least one discontinuous phase (B), in which at least one adsorbent is not fluidly connected to the others and in which the components of the desired product (P) are recovered in purified form from a disconnected adsorbent, in which the process comprises, at a minimum, the following steps: a. chromatogram monitoring including measurement of at least one signal proportional to the current concentration in the liquid; b. chromatogram evaluation that includes a comparison of at least one of said signals proportional to the current concentration measured in step a. with a threshold value of it; c. control of the chromatographic purification procedure by adapting the termination of the currently running phase based on the comparison of step b. and start of the next phase, in which the sequence from a-c is carried out in a certain order, at least twice.