Proteolysis resistant antibody preparations

Details Proteolysis resistant antibody preparations Proteolysis resistant antibody preparations

A - Human Necessities

61

K

A61K 39/395 (2006.01) C12P 21/06 (2006.01)

Patent

CA 2619825

Antibody preparations with substantially homogeneous and unsialylated glycoforms, such as G0 and G2, are prepared by enzymatic treatment, expression under certain conditions, use of particular host cells, and contact with serum. These antibody preparations resist cleavage by proteases, such as papain, ficin, bromolein, pepsin, a matrix metalloproteinase, such as MMP-7, neutrophil elastase (HNE), stromelysin (MMP-3) and macrophage elastase (MMP- 12), and glycosylation modification enzymes. The antibody preparations with substantially homogeneous and unsialylated glycoforms and methods of testing for glycosylation in an antibody are useful in connection with characterization of antibody properties and/or in diseases or conditions characterized by an increase in protease activity.

La présente invention concerne des préparations d'anticorps qui ont des glycoformes sensiblement homogènes et non sialylées, telles que G0 et G2. Ces préparations sont obtenues par un traitement enzymatique, l'expression dans certaines conditions, l'utilisation de cellules hôtes particulières, et le contact avec du sérum. Ces préparations d'anticorps résistent au clivage par des protéases telles que la papaïne, la ficine, la bromoléine, la pepsine, une métalloprotéase matricielle telle que MMP-7, une élastase neutrophile (HNE), la stromélysine (MMP-3) et une élastase macrophage (MMP-12), et des enzymes de modification de glycosylation. Les préparations d'anticorps ayant des glycoformes sensiblement homogènes et non sialylées, et des procédés pour tester la glycosylation dans un anticorps, sont utiles en connexion avec la caractérisation de propriétés d'anticorps et/ou dans le cadre de maladies ou d'états pathologiques qui se caractérisent par l'augmentation de l'activité des protéases.

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