Methods and systems for chromatography data analysis
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsNathan L. Mao, Eric Shierly, Bernhard Schilling, Scott Carver, Stefanie McDermott, John Mattila, Hanne Bak
Life of this patent
Estimating the term…
Abstract
Embodiments of the present disclosure are directed to methods and systems for assessing integrity of chromatography columns, systems, and processes. The methods and systems can comprise one or more of extracting a block and signal combination for analysis, performing a transition analysis, performing one or more statistical process controls, and/or implementing in-process controls based on the statistical process controls.
Claims20
A process control method, comprising:
- generating smoothed data by applying a noise reduction technique to raw chromatography data, wherein the noise reduction technique comprises using a smoothing filter on a portion of raw chromatography data to generate smoothed data;
- generating processed chromatography data by selecting smoothed data matching a feature of a chromatogram transition;
- performing a transition analysis to generate transition data;
- and
- performing an action based on the transition data, wherein performing the action includes generating a notification of an event, generating an evaluation of the event, or generating a deviation notification form.
A process control method, comprising:
- processing raw chromatography data including a plurality of signals and a plurality of blocks, to generate processed raw chromatography data by applying a noise reduction technique to the plurality of signals and the plurality of blocks;
- performing a transition analysis on the processed raw chromatography data, to generate transition data, wherein performing the transition analysis includes:
- generating a curve using the processed chromatography data;
- analyzing the curve to generate a performance parameter;
- and
- generating the transition data based on the performance parameter;
- and
- performing an action based on the transition data, wherein performing the action includes generating a notification of an event, generating an evaluation of the event, or generating a deviation notification form.
A process control method, comprising:
- generating smoothed data by applying a noise reduction technique to raw chromatography data, wherein the noise reduction technique comprises:
- selecting a portion of raw chromatography data using predetermined set points;
- and
- using a smoothing filter on the portion of raw chromatography data to generate smoothed data;
- generating a performance parameter based on the smoothed data, wherein the performance parameter includes:
- a maximum rate of change;
- a number of inflection points;
- a breakthrough volume;
- a cumulative error;
- a curve asymmetry;
- a height equivalent of a theoretical plate;
- or
- a combination thereof;
- generating transition data based on the performance parameter;
- and
- performing an action based on the transition data, wherein performing an action includes generating a notification of an event, generating an evaluation of the event, or generating a deviation notification form.
Dependencies are inferred from the claim text.