Process for improving Omalizumab expression in CHO cells
AssigneeKashiv Biosciences, LLC
InventorsKaumil Bhupendra Bhai Bhavsar, Ghanshyam Madhabhai Patel, Parth Hitarthbhai Vaishnav
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Abstract
The present invention relates to a process of improving the production of anti-IgE antibody specifically Omalizumab with improved titer and reduced galactosylation and/or reduced acidic variant expressed in mammalian cell culture in suitable culture condition for an example using fed batch mode by maintaining specific temperature 36.5° C.±0.5 throughout the duration of cells culture.
Claims12
A process for improving the expression of omalizumab in Chinese Hamster Ovary cell culture comprising;
- a) culturing the Chinese Hamster Ovary cells capable to express omalizumab in the Chinese Hamster Ovary cell culture;
- b) maintaining suitable temperature at 36.5° C. throughout the Chinese Hamster Ovary cell culture;
- c) harvesting the omalizumab from the Chinese Hamster Ovary cell culture,
- wherein the process improves titer of the omalizumab compared to cell culture process performed at temperature 35.5° C. or 37.5° C., and
- wherein the process reduces total galactosylation of the omalizumab or reduces expression of acidic variants of the omalizumab compared to cell culture process performed at temperature 35.5° C. or 37.5° C.
A process for improving the expression of omalizumab in Chinese Hamster Ovary cell culture comprising:
- a) culturing the Chinese Hamster Ovary cells capable to express omalizumab in the Chinese Hamster Ovary cell culture;
- b) maintaining temperature 36.5° C. throughout the Chinese Hamster Ovary cell culture;
- c) maintaining pH 6.8±0.1 during the production phase of mammalian cell culture;
- d) harvesting omalizumab from Chinese Hamster Ovary cell culture,
- wherein the process improves titer of the omalizumab compared to cell culture process performed at temperature 35.5° C. or 37.5° C., and
- wherein the process results in total galactosylation of the omalizumab of 8%±0.8% to 12%±1.2% compared to cell culture process performed at temperature 35.5° C. or 37.5° C. or wherein the process results in expression of acidic variants of the omalizumab of 12%±1.2% to 16%±1.6% compared to cell culture process performed at temperature 35.5° C. or 37.5° C.
Dependencies are inferred from the claim text.