Scale up study and comparison of three downstream processes of monoclonal antibody production using superpro designer

The main purpose of this study is to simulate the large scale production of monoclonal antibody (mAb) by using SuperPro Designer (SPD). Since the first discovery of mAb at 1970s, this type of antibody had become the most rapidly growing class of pharmaceutical. Problem with mAb production is the high cost and low amount of production but high demand for this therapeutic. In order to overcome this problem, large scale production had become one of the top priorities for mAb production. Large scale simulation study by using SPD can minimize time and cost production by eliminate the high cost of trial-and-error steps, as well as to find and simulate the optimization process for mAb production. In order to achieve the objective of this research, study is conducted in two steps which are simulation on the upstream and downstream process. For the upstream process, the stoichiometric equation is constructed base on the laboratory data and used to simulate the large volume of fermenter. For a downstream process, three flow of downstream process from different source a built, simulated and compared to choose the best process for purification of mAb. The result shows that the upstream process for 20000 L fermenter produced 0.00510 kg/Batch of mAb with concentration of 3.8 × 10-4 g/L (5.1103 g/Batch). Compared to the flow from SPD source and journal (S. Sommerfeld and J. Strube, 2005), the best downstream process was the flow from Inno Biologics Sdn.Bhd that yield 81% of mAb with a concentration of 4.14328 g/Batch. As a conclusion, the simulation of large scale production of mAb by using SPD are flow work for 20000 L of fermenter as upstream process and Inno Biologics Sdn. Bhd. flow work as downstream process.