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US 12,595,294 B2Granted
Methods to decrease impurities from recombinant protein manufacturing processes
AssigneeHoffmann-La Roche Inc.
InventorsMarc Pompiati, Christoph Feistl
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Abstract
The invention relates to a method of reducing the amount of non-aggregate produce-related impurities (NAPRIs) in a buffered solution of monoclonal antibodies (mAbs), involving the use of a synthetic depth filter. The invention may be of use in the purification of monoclonal 5 antibodies.
Claims15
A method of producing a buffered solution of monoclonal antibodies (mAbs) with a reduced amount of non-aggregate product-related impurities (NAPRIs), the method comprising passing an initial buffered solution comprising:
- (a) mAbs, and (b) NAPRIs, through a synthetic depth filter comprising silica and polyacrylic fiber to produce the buffered solution of mAbs with the reduced amount of NAPRIs,
- wherein the NAPRIs comprise incompletely or incorrectly assembled mAb polypeptides,
- wherein the NAPRIs comprise high molecular weight (HMW) polypeptides having a molecular weight higher than the mAb,
- wherein the NAPRIs do not comprise aggregates, and
- wherein the reduced amount of NAPRIs is with respect to the amount of NAPRIs in the initial buffered solution before it has passed through the synthetic depth filter comprising silica and polyacrylic fiber.
2 more elements
Dependencies are inferred from the claim text.