Purification process for fragment antibodies

摘要

A process for purification of a fragment antibody from a culture medium also comprising at least one impurity is provided. The purification is carried out after the pH of the culture medium has been reduced to a pH at which the fragment antibody is soluble, but one or more of the impurities are insoluble. A process for the preparation of a fragment antibody employing such a purification process is also provided.

主权项

1. A process of purifying a fragment antibody selected from the group consisting of a bispecific ScFv, ScFV fragment, Fab fragment, Fab2, Fab3, minibody, diabody, triabody, single-domain antibody, tetrabody, and multivalent antibody fragment derived tandem antibody fragment from a culture medium comprising at least one impurity comprising:
separating the fragment antibody from the culture medium, wherein the culture medium is prepared by expression of an expression cassette encoding the fragment antibody in a recombinant prokaryotic host cell and subsequent lysis or disruption of the host cell, the separation is carried out after reducing the pH of the culture medium to a pH at which the fragment antibody is soluble, but one or more of the impurities are insoluble, and if a chromatographic method is performed, said reducing the pH of the culture medium is performed prior to the chromatographic method.