REMOVAL OF α-GAL EPITOPES FROM THERAPEUTIC GLYCOPROTEINS FOR AVOIDING INTERACTION WITH THE ANTI-GAL ANTIBODY

摘要

The invention provides methods comprising applying a therapeutic glycoprotein preparation having one or more α-gal epitopes having a terminal Gala α1-3Gal or terminal α-galactosyls to a column having covalently or non-covalently coupled α-galactosidase in porous beads or on particulate material in order to destroy the α-gal epitope by enzymatic removal of the terminal galactose by the α-galactosidase. The invention further provides methods comprising destruction of one or more α-gal epitopes having a terminal Gala α1-3Gal or terminal a- galactosyls on therapeutic glycoproteins by mixing the glycoproteins with tagged α- galactosidase in order to destroy the α-gal epitope by enzymatic removal of the terminal galactose and to subsequently remove the α-galactosidase.