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US 2022/0033487 A1Published application
Methods of Producing Ustekinumab
AssigneeMomenta Pharmaceuticals, Inc.
InventorRu Zang
Life of this patent
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Abstract
Methods of manufacturing an ustekinumab product with a target level of one or more glycans are described.
Claims12
A method of manufacturing a pharmaceutical composition comprising ustekinumab having a target level of G0F glycan, the method comprising:
- (a) selecting a target level of G0F glycan,
- (b) selecting a level of galactose and a time for cell culture to provide the selected level of G0F glycan, wherein the level of galactose and the time are inversely related;
- (c) culturing a population of cells genetically engineered to express ustekinumab under conditions comprising the selected level of galactose and time;
- (d) harvesting ustekinumab expressed by the population of cells, thereby producing the preparation of ustekinumab;
- and
- (e) purifying, concentrating, and/or formulating the ustekinumab preparation to produce pharmaceutical composition comprising ustekinumab if the preparation meets the target level of G0F glycan.
3 more elements
Dependencies are inferred from the claim text.