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

Claim 13:
14. A non-transitory computer-readable storage medium with an executable program stored thereon for detecting chromatography column deterioration in a chromatography system, wherein the program instructs a microprocessor to perform the steps of:
(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 one or more 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; and
(h) optimizing and validating the generated OPLS model, and

(ii) acquiring one or more chromatogram ultraviolet (UV) traces generated by a chromatography system during sample purification and/or separation; and
(iii) analyzing the one or more acquired chromatogram UV traces with the OPLS model, thereby allowing detection of column deterioration prior to column failure and quantitative analysis of UV signal in the one or more chromatogram UV traces.