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ChemSim has created many process models for production of monoclonal antibodies and other biologics. Over the years process conditions have changed, and today many of the processes run at much higher titers. This increase in titer has affected process designs and increased the use of smaller volume (1000-2000L), disposable bioreactors, compared to the older, standard 15,000L stainless steel bioreactors. Downstream processing has also evolved. Protein A is still the main step for initial purification, but resins have increased dynamic capacities to handle the higher titer fermentations. Processing more material downstream can result in higher volumes of buffers for the different chromatography steps. This increased requirement for buffer can be addressed by using buffer concentrates and in-line dilution at the chromatography skid.
Balancing the increased productivity in the bioreactor, with downstream purification can be a challenge, and process models can be used to study different production scenarios, and help validate initial design concepts. Accurate in-silico models are used to track the on-going process and to determine opportunities to optimize throughput for increased productivity. |
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