![]() Therapeutic monoclonal antibodies and derivatives:historical perspectives and future directions. ![]() The therapeutic monoclonal antibody market. 6th annual European antibody congress 2010. Antibodies and cancer therapy:versatile platforms for cancer immunotherapy. Key words: monoclonal antibody, process simulation, economic evaluation, hotspots analysis, process optimization The results demonstrated that with the aid of reasonable process simulation and economic evaluation, some hotspots of manufacture process could be identified and the appropriate optimization strategies would be proposed to improve the process efficiency and reduce the production cost. The optimization of overall process would be the stagger mode with three main bioreactors corresponding one downstream line, for which the production scale and equipment cost were two key factors. The downstream optimization should focus on Protein A affinity resins, including capacity,price and the reuse cycles. But when the titer was higher than 5 g/L, the effect of titer increasing on the cost was weakened and the cost was then mainly controlled by downstream process. ![]() The key for upstream optimization was to increase the titer of mAb expression during cell culture. With the increase of production scale, the cost would be significantly reduced, and the economic hotspots were transferred from equipment-dependent costs to raw materials and consumables, including serum-free medium and Protein A affinity resin. The results showed that the scale effect on the production cost was obvious. Through the process analysis and cost evaluation, the economic 'hotspots' were determined and the optimization strategies were then proposed. In this paper, four scales of mAb manufacturing processes of 500, 2000, 500 L were established by using SuperPro Designer software, a bioprocess simulation software. With the continuous expansion of industrial-scale production and competition, the process rationality and economy have attracted more and more attention. ![]() Monoclonal antibody (mAb) is the most important biopharmaceuticals. ![]()
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