Monoclonal antibodies (mAbs) are used to treat a range of diseases such as cancers, autoimmune diseases, diabetes, and celiac disease. In the current market there is a preference for human mAbs and a majority of mAbs are produced in Chinese Hamster Ovary (CHO) cells. CHO cells are genetically modified to create clones that will produce the mAb of choice. The CHO cell culture process has been optimized to support high cell densities, cell viabilities, and mAb titers. With the growing demand for mAb therapies, research and development groups are looking for ways to increase titers either through optimizing culture parameters to produce more antibody, or by making the process more efficient, allowing for more production runs to be completed in the same amount of time. At Sanofi, efforts were made to test and implement single use bioreactor technology in order to make the workflow more efficient. The Mobius single use 3L bioreactor was evaluated against the existing platform glass reactors in a fourteen day fed-batch process. Key culture parameters such as cell density, viability, and mAb titer were measured as well as important metabolites such as glucose, glutamine, glutamate, lactate, ammonia, and lactate dehydrogenase. The Mobius single use bioreactor was comparable to the glass vessels in terms of cell density, viability, mAb titer, and metabolites. Compared to the glass vessels, the Mobius bioreactor required less operator time to set up. The Mobius reactor is a pre-made vessel so no changes can be made to the design, making it difficult to adapt the reactor to developing processes. In the preliminary experiments, the Mobius reactor matched the performance of the existing glass reactors in most key parameters, but additional experimentation is ongoing to evaluate single use bioreactor culture for mAb production.
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