Process for controlling sialylation of proteins produced by mamma lian cell culture, production method of chimerical protein of tum our necrotic factor with immunoglobulin, preparation and therapeu tic composition containing it

摘要

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 tumour necrosis factor immunoglobulin G1 and their uses in the treatment of inflammatory or immune related disorders.