High pressure refolding of monoclonal antibody aggregates

摘要

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.

主权项

1. 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.