Mammalian cell culture process

Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Structurally-modified antibody – immunoglobulin – or fragment...

Reexamination Certificate

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C424S130100, C424S133100, C424S142100, C424S145100, C514S002600, C514S008100, C530S350000, C530S387100, C530S395000, C435S069700, C435S325000, C435S375000

Reexamination Certificate

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07666416

ABSTRACT:
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.

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