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US 12,754,181 B2Granted
Extraction methods for evaluating suitability of a biochemical filter
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsNathan Mao, Annamarie Cruz, Bernhard Schilling, Scott Carver
Life of this patent
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Abstract
Embodiments of the present disclosure include methods and systems for detecting the presence of endotoxins in filters. For example, embodiments of the present disclosure are directed to methods and systems for improving in-process controls by detecting undesirable quantities of endotoxins in filters containing naturally-sourced materials prior to using those filters in the production of formulated drug substances.
Claims19
A method, comprising:
- selecting a filter from a plurality of filters, wherein each of the plurality of filters comprises cellulose and/or diatomaceous earth;
- passing a volume of a buffer solution through the selected filter, wherein the buffer solution is configured to remove endotoxins from the selected filter, and wherein the buffer solution has a conductivity of at least about 40 mS/cm at 25° C. when tested in accordance with ASTM D1125;
- performing an assay of the buffer solution passed through the selected filter to detect a presence of an endotoxin removed from the selected filter;
- and
- evaluating a suitability of the plurality of filters based on a result of the assay.
2 more elements
A method, comprising:
- contacting a naturally-sourced material with a buffer solution, wherein the naturally-sourced material comprises cellulose and/or diatomaceous earth, wherein the buffer solution is configured to remove an endotoxin from the naturally-sourced material, and the buffer solution has a conductivity of at least about 40 mS/cm at 25° C. when tested in accordance with ASTM D1125;
- and
- performing an assay of the buffer solution to detect a presence of the endotoxin removed from the naturally-sourced material in the buffer solution.
A method comprising:
- passing a buffer solution through a first filter of a filter lot, the filter lot including a plurality of filters comprising naturally-sourced materials, and the buffer solution is configured to remove an endotoxin from the first filter;
- assaying the buffer solution passed through the first filter to detect a quantity of the endotoxin removed from the first filter and present in the buffer solution;
- passing a cell culture fluid through a second filter of the filter lot;
- assaying the cell culture fluid passed through the second filter to detect a quantity of the endotoxin removed from the second filter and present in the cell culture fluid;
- and
- comparing the quantity of the endotoxin detected in the buffer solution to the quantity of the endotoxin detected in the cell culture fluid,
- wherein the naturally-sourced materials include one of cellulose and/or diatomaceous earth.
4 more elements
A method comprising:
- passing a buffer solution through a filter, wherein the buffer solution is configured to remove endotoxins from the filter, thereby washing endotoxins from the filter before use, and
- assaying the buffer solution passed through the filter to determine a quantity of endotoxin in the buffer solution, wherein the buffer solution comprises tris(hydroxymethyl)aminomethane, citrate, histidine, arginine, or a combination thereof, and has a conductivity of at least about 40 mS/cm at 25° C. when tested in accordance with ASTM D1125;
- wherein the filter is a harvest depth filter, the harvest depth filter comprises naturally-sourced materials and the naturally-sourced materials comprise cellulose and/or diatomaceous earth.
Dependencies are inferred from the claim text.