PRODUCT QUALITY ATTRIBUTE MEASUREMENT Russian patent published in 2024 - IPC G01N30/42 

FIELD: physics.

SUBSTANCE: present invention relates to systems and methods for measuring quality attribute of a product for samples, including samples collected in continuous bio-production systems. System for measuring a quality attribute of a product for an analyte of a biological sample comprises: the first flow control device; a device for cleaning samples in fluid communication with the first flow control device; the second flow control device in fluid communication with the first flow control device, with the sample cleaning device and with the first and second sample analysers, wherein the first sample analyser comprises a first chromatographic column; and a control unit connected to the first and second flow control devices and configured so that during operation of the system, the control unit: (a) adjusts the configuration of the first flow control device to direct the first portion of the biological sample from the first flow control device or to the sample cleaning device, either into the second flow control device so that this part of the biological sample is received in the second flow control device; (b) adjusting the second flow control device configuration to direct the first portion of the biological sample to one of the first and second sample analysers; (c) determines a first product quality attribute for an analyte of a biological sample based on analysis of the first portion of the biological sample by one of the first and second sample analysers; (d) adjusting the configuration of the first flow control device to direct the second portion of the biological sample from the first flow control device or to the sample cleaning device, either into the second flow control device so that the second part of the biological sample is received in the second flow control device; (e) adjusting the second flow control device configuration to direct the second portion of the biological sample to one of the first and second sample analysers which did not receive the first portion of the biological sample; and (f) determining a second product quality attribute for the analyte of the biological sample based on analysis of the second portion of the biological sample by one of the first and second sample analysers which received the second portion of the biological sample, wherein the first and second quality attributes of the product are different, and wherein each of the first and second quality attributes of the product is selected from a group consisting of the concentration of the analyte in the biological sample, a measure of aggregation of the analyte in the biological sample, measures of different charge variants or heterogeneity of analyte in biological sample and measures of purity or integrity of analyte in biological sample.

EFFECT: possibility of controlling and correcting a wide range of bioprocess conditions.

17 cl, 16 dwg, 4 tbl