Antibody formulation

A - Human Necessities – 61 – K

Patent

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Details

A61K 39/00 (2006.01) A61K 39/395 (2006.01)

Patent

CA 2642270

The present invention provides formulations and methods for the stabilization of antibodies. In one embodiment, the invention provides the stabile formulation of antibodies that are prone to non-enzymatic fragmentation at the hinge region. In a further embodiment, the invention provides methods of stabilization of antibodies comprising lyophilizing an aqueous formulation of an antibody. The formulations can be lyophilized to stabilize the antibodies during processing and storage, and then the formulations can be reconstituted for pharmaceutical administration. In one embodiment, the present invention provides methods of stabilization of anti- VEGFR antibodies comprising lyophilizing an aqueous formulation of an anti-VEGFR antibody. The formulations can be lyophilized to stabilize the ahti-VEGFR antibodies during processing and storage, and then the formulations can be reconstituted for pharmaceutical administration.

La présente invention concerne des formulations et des procédés pour la stabilisation d'anticorps. Dans un mode de réalisation, l'invention propose la formulation stable d'anticorps qui sont disposés à une fragmentation non-enzymatique en la région charnière. Dans un autre mode de réalisation, l'invention propose des procédés de stabilisation d'anticorps comprenant de lyophiliser une formulation aqueuse d'un anticorps. Les formulations peuvent être lyophilisées de manière à stabiliser les anticorps pendant le traitement et le stockage, et ensuite les formulations peuvent être reconstituées pour une administration pharmaceutique. Dans un mode de réalisation, la présente invention propose des procédés de stabilisation d'anticorps anti-VEGFR comprenant de lyophiliser une formulation aqueuse d'un anticorps anti-VEGFR. Les formulations peuvent être lyophilisées de manière à stabiliser les anticorps anti-VEGFR pendant le traitement et le stockage, et ensuite les formulations peuvent être reconstituées pour une administration pharmaceutique.

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