Patent ID: 11885779
Assignee: REGENERON PHARMACEUTICALS, INC.
Field: Measurement (Instruments)
Classification: CPC G | IPC G

Claim 0:
1. A method of detecting chromatography column deterioration prior to column failure in a chromatography system, comprising:
(i) creating an orthogonal partial least square (OPLS) model, wherein creating the OPLS model comprises:
(a) selecting a process or unit operation for which the OPLS model is being created,
(b) collecting raw data for ultraviolet (UV) chromatogram traces of one or more column cycles/lots/runs for the selected process or unit operation,
(c) normalizing and aligning the collected raw data,
(d) generating artificially created curves from normalized raw data,
(e) classifying and formatting data for importation into a multivariate tool,
(f) importing classified and formatted data into the multivariate tool to generate a training set of chromatogram traces, wherein the artificially created curves are classified as “undesirable” chromatogram traces in the training set,
(g) generating the OPLS model from the multivariate tool using the training set,
(h) optimizing and validating the generated OPLS model; and

(ii) acquiring one or more chromatogram ultraviolet (UV) traces generated by a chromatography system during the selected process or unit operation; and
(iii) applying the OPLS model to the one or more chromatogram UV traces, thereby allowing detection of column deterioration prior to column failure.