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US 8,802,828 B2Granted
High pressure refolding of monoclonal antibody aggregates
AssigneeBarofold, Inc.
InventorsMatthew B. Seefeldt, Robert Nelson, Theodore W. Randolph, Lyndal K. Hesterberg
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Abstract
Methods for refolding antibodies, particularly monoclonal antibodies, from aggregated and/or denatured preparations by subjecting the antibody preparation to high hydrostatic pressure are provided. Refolded preparations of antibodies produced by the methods described herein are also provided.
Claims5
A method for refolding a sample of abatacept, comprising the steps of:
- (a) obtaining an abatacept sample comprising a solution of abatacept exposed to a pH of about 3 and containing from 15% to 21% acid-induced aggregates;
- (b) adjusting the of the solution to above 5;
- (c) exposing the abatacept to an increased hydrostatic pressure of about 1000 bar to about 3000 bar for a period of time;
- and
- (d) reducing the hydrostatic pressure to atmospheric pressure;
- wherein the sample of abatacept after exposure to increased hydrostatic pressure has less than about 1% abatacept aggregates than the abatacept sample prior to the increased pressure exposure.
3 more elements
Dependencies are inferred from the claim text.