Monoclonal antibodies intended for use as therapeutic agents must be produced in large quantities due to their high in vivo dosages. 1Therefore, development of a cost-effective process that can be scaled-up without affecting product quality, is critical. It is also essential that the process be capable of producing consistent batches under CGMP regulations. In developing such a production strategy, the various process elements, from cell line and media to bioreactor design and control, must be critically examined and integrated using systems-level approach. Figure 1 illustrates a schematic for such an approach.
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