ABSTRACT

Pharmaceutical biotechnology has a long-standing history dating back to the previous century, initially exhibited by the low-molecular-weight compounds biosynthesis such as penicillin and streptomycin. Pharmaceutical biotechnology remains grounded in bioprocessing and fermentation. However, advancements in biotechnology and pharmaceutical sciences have brought about a paradigm shift, leading to a clear definition of the field. The revolution of biotechnology altered the process of drug research, development, production, and marketing. New cutting-edge tools and biotechnology-related fields like genomics and proteomics are now available to study and utilize protein and molecular behavior. The recombinant DNA (rDNA) techniques include genetic, protein, and metabolic engineering, allowing the synthesis of a variety of peptides, proteins, and biochemicals using cells that do not naturally produce them. Synthetic biology constitutes the design and creation of new biological components such as enzymes, circuits, modules, or systems, as well as redesigning existing biological systems by reprogramming genetic information for useful applications. Although its origins trace back to the 1960s, synthetic biology has experienced rapid growth over the past decade. This progress is mainly due to the decreasing cost of DNA synthesis, advancements in genetic engineering, and improved knowledge of genome organization and data science. However, much remains obscure regarding the application of synthetic biology in the pharmaceutical industry. In this chapter, we give recent examples of synthetic biology impacts on target validation, assay development, hit finding, lead optimization, and chemical synthesis, all driven by the creation of cellular therapeutics. This chapter emphasizes the tools and technologies fueling this discipline. Synthetic biology is indeed affecting every stage of drug discovery and development, and acknowledging the discipline’s contribution would significantly enhance prospects for the drug discovery and development value chain.