This thesis consists of two chapters. Using protein drug as an example, the first chapter outlines a systematic procedure for the process synthesis and development of high-value biopharmaceutical production plants. The procedure decomposes a generic protein drug manufacturing process into a series of processing steps. First, the most appropriate separation technique is chosen for each processing step. Then the most suitable equipment will be selected for each unit operation. Finally, operating conditions will be set for each piece of equipment and process optimization will be attempted. Design heuristics and physical models describing relevant physical phenomena are provided to assist decision-making in the procedure. Real examples (interferon α and tissue plasminogen activator) are emp...[ Read more ]

This thesis consists of two chapters. Using protein drug as an example, the first chapter outlines a systematic procedure for the process synthesis and development of high-value biopharmaceutical production plants. The procedure decomposes a generic protein drug manufacturing process into a series of processing steps. First, the most appropriate separation technique is chosen for each processing step. Then the most suitable equipment will be selected for each unit operation. Finally, operating conditions will be set for each piece of equipment and process optimization will be attempted. Design heuristics and physical models describing relevant physical phenomena are provided to assist decision-making in the procedure. Real examples (interferon α and tissue plasminogen activator) are employed at the end to illustrate how to use the systematic procedure.

The second chapter explains about the process synthesis and development for antibiotics, a generic kind of high-volume biopharmaceuticals. With the ultimate goal of planning feasible antibiotic plants, this chapter demonstrates the possibility of applying the same systematic procedure as the one in the first chapter with modifications, the contrasts between protein drug processes and antibiotic processes, and the reasons behind the differences.

Putting the two chapters aforementioned together, the author aims at providing any reader with a balanced view on biopharmaceutical process synthesis.