Stabilised antibodies

A - Human Necessities – 61 – K

Patent

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Details

IPC codes

A61K 39/395 (2006.01) A61K 47/18 (2006.01) C07K 16/00 (2006.01) A61K 38/00 (2006.01)

Type

Patent

Patent number

CA 2121257

Description

The invention relates to a stabilised immunoglobulin composition comprising at least one immunoglobulin together with a stabilising amount of a chelator of copper ions such as EDTA or citrate. Preferably the immunoglobulin is an antibody, for example a recombinant CDR-grafted antibody against the CDw52 antigen, most preferably CAMPATH-1H. The invention also relates to a process for enhancing the stability of an immunoglobulin which comprises subjecting the immunoglobulin to a purification procedure capable of removing copper ions therefrom. Preferably the immunoglobulin is rendered substantially free from detectable copper ions, for example on atomic absorption spectroscopy.

L'invention se rapporte à une composition d'immunoglobulines stabilisées comprenant au moins une immunoglobuline ainsi qu'une quantité stabilisante d'un agent chélatant d'ions cuivre tel que l'EDTA ou le citrate. De préférence, l'immunoglobuline est un anticorps, par exemple un anticorps greffé en CDR recombinant dirigé contre l'antigène CDw52, de préférence le CAMPATH-1H. L'invention se rapporte également à un procédé destiné à augmenter la stabilité d'une immunoglobuline qui consiste à soumettre l'immunoglobuline à une procédure de purification capable de supprimer les ions cuivre présents sur celle-ci. De préférence, l'immunoglobuline est rendue sensiblement dépourvue d'ions cuivre détectables, par exemple par spéctroscopie avec absorption atomique.

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