Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry: Using Chemistry and Bioengineering to Improve the Performance of Biologics

The explosion and exploitation of biotechnology and bioengineering toward the end of the twentieth century led to the invention of valuable biologic drugs for the benefit of patients around the world. Opportunities continue to expand in dramatic and unforeseen ways through the present time. Advances in individual fields as well as multidisciplinary integration across science, technology, and bioengineering drive this innovation, emphasizing the importance of reducing timelines and cost for drug development and clinical studies, all under a regulatory and ethical framework that is vital for delivering safe and effective therapies to patients. Medical disorders with associated genetic components and the understanding of single mutations in disorders like sickle-cell disease, cystic fibrosis, and progeria have led to possible solutions by synthetic biologists for such diseases. The latest advancements in synthetic biology and emerging new technologies manifested in uncovering the expression of monoclonal antibodies, antibody drug conjugates (ADCs), gene therapy and immunotherapies, cell therapies (e.g., CAR-T [Chimeric Antigen Receptor-engineered T-cells]), gene editing (e.g., CRISPR [Clustered Regularly Interspaced Short Palindromic Repeats]), and vaccines among other applications. Efficient processes for generating monoclonal antibodies, gene therapy, and cell therapy products require significant advances in upstream and downstream processes, analytical methods, as well as automation leading to process efficiencies and green processes. The opening chapter discusses the differences and the relationship between small molecules and biologic drugs and topics representing the latest advances of bioprocessing, bioengineering, and process chemistry in biologics and biotechnology applications of interest to global readers from both industry and academia.