Methods and systems for assessing chromatographic column integrity
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsEric SHIERLY, Kevin BRENNAN, Donald CROSS
Life of this patent
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Abstract
A chromatographic column analog may include chromatography media. The chromatographic column analog may further include a void configured to create a zone of preferential flow within the chromatography media, a block configured to create a zone of reduced flow within the chromatography media, or a void and a block. The block may include a top face, a bottom face, and a thickness between the top face and the bottom face. A width of a top or bottom face of the block may be about 50 percent to about 90 percent of an inner diameter of the analog.
Claims20
A chromatographic column analog comprising:
- chromatography media;
- and
- one or more of:
- a void configured to create a zone of preferential flow within the chromatography media;
- or
- a block configured to create a zone of reduced flow within the chromatography media.
A chromatographic column analog comprising:
- chromatography media;
- and
- one or more of:
- a void that does not include chromatography media, wherein the void is permeable to water;
- or
- a block that does not include chromatography media, wherein the block is impermeable to water.
A method of developing a pre-use assessment protocol, the method comprising:
- performing a first iteration of a chromatography operation using a chromatography column, thereby generating a first chromatogram and a first product pool;
- performing a second iteration of the chromatography operation using a channeling analog, thereby generating a second chromatogram and a second product pool;
- performing a third iteration of a chromatography operation using a blocking analog, thereby generating a third chromatogram and a third product pool;
- analyzing the product quality of the first product pool, the second product pool, and the third product pool;
- determining one or more peak characteristics of the first chromatogram, the second chromatogram, and the third chromatogram;
- and
- determining a relationship between product quality and the one or more peak characteristics.
Dependencies are inferred from the claim text.