Process for controlling sialylation of proteins produced by...

C - Chemistry – Metallurgy – 07 – K

Patent

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C07K 19/00 (2006.01) A61K 38/19 (2006.01) A61K 39/395 (2006.01) A61K 47/48 (2006.01) C07K 14/715 (2006.01) C07K 16/00 (2006.01) C07K 16/18 (2006.01) C12N 5/00 (2006.01) C12P 21/02 (2006.01) A61K 38/00 (2006.01)

Patent

CA 2220684

The present invention relates to novel process for the preparation of glycoproteins by mammalian cell culture wherein the sialic acid content of the glycoprotein produced is controlled over a broad range of values by manipulating the cell culture environment. The invention provides for processes in which the sialic acid content of the glycoprotein is modified by changes in cell culture parameters which affect cell specific productivity. Preferred embodiments of the invention include cell culture processes in the osmolality of the cell culture is controlled as well as the concentration of a transcription enhancer during the production phase of the cell culture. The invention further provides for novel preparations of soluble type 1 tumor necrosis factor immunoglobulin G1 and their uses in the treatment of inflammatory or immune related disorders.

L'invention concerne un nouveau procédé de préparation de glycoprotéines par une culture de cellules de mammifères, dans lequel la teneur en acide sialique de la glycoprotéine produite est régulée sur une large gamme de valeurs par manipulation de l'environnement de la culture de cellules. L'invention concerne des procédés dans lesquels la teneur en acide sialique de la glycoprotéine est modifiée par des changements dans les paramètres de la culture cellulaire, lesquels modifient la productivité spécifique cellulaire. On peut citer parmi des modes de réalisation préférés de l'invention des procédés de culture cellulaire dans lesquels l'osmolalité de la culture cellulaire est régulée ainsi que la concentration d'un activateur de transcription pendant la phase de production de ladite culture cellulaire. L'invention concerne en outre de nouvelles préparations du facteur de nécrose tumorale de type 1-immunoglobuline G1 solubles et leurs utilisations dans le traitement de troubles inflammatoires ou immuns.

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