An Improved Cell Culture Process for Production of Omalizumab
The demand for biopharmaceutical products such as monoclonal antibodies (MAbs), fusion proteins, viral vaccines, and hormones is rapidly increasing. Mammalian cell cultures with ease of process operations are adopted to get the desired product. The challenges of low productivity and impurities in the desired product can be eliminated by optimizing the process parameters. The present study focuses on the optimization of temperature with other parameters to achieve improved titer and reduced heterogeneity in Omalizumab. An anti-IgE antibody expressed in mammalian cell culture. It is noticed that maintaining a specific temperature of 36.5° C ± 0.5 and pH 6.8± 0.1 during fed-batch cell culture provides improved quality (reduced galactosylation and reduced acidic variants) and quantity (improved titer) of the Omalizumab.
Keywords: antibody, omalizumab, mammalian cells, acidic variants
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