METHODS TO CONTROL PROTEIN HETEROGENEITY

摘要

The instant invention relates to the field of protein production, and in particular to compositions and processes for controlling and limiting the heterogeneity of proteins expressed in host cells.

主权项

1. A process for producing a recombinantly-expressed immunoglobulin, comprising culturing a mammalian cell which recombinantly expresses the immunoglobulin during a production stage in a cell culture media comprising asparagine, thereby producing the recombinantly-expressed immunoglobulin,
wherein the level of agalactosyl fucosylated biantennary oligosaccharides (sum of NGA2F and NGA2F−GlcNac) present on the produced immunoglobulin is increased as compared to the level of agalactosyl fucosylated biantennary oligosaccharides (sum of NGA2F and NGA2F−GlcNac) of immunoglobulin produced in cell culture media which does not comprise said asparagine during the production stage; and/or wherein the level of galactose containing fucosylated biantennary oligossacharides (sum of NA1F and NA2F) present on the produced immunoglobulin is decreased as compared to the level of galactose containing fucosylated biantennary oligossacharides (sum of NA1F and NA2F) of immunoglobulin produced in cell culture media which does not comprise said asparagine during the production stage.