Chapter 1. Introduction to Biopharmaceuticals

Summary

Since the discovery in 1800 that the human body is composed of cells and proteins, the cast and characters that are targets as well as the ability of the host to fight microbes and diseases, exponential growth in the knowledge and enabling technologies have allowed consistent production of high quality proteins, antibodies and peptides for pharmaceutical applications. While biotechnology may be synonymous to advanced technologies today, the technology of using biological entities as therapeutic has been in existence since the 1800's. Recent achievements in refinement to produce recombinant macromolecules and monoclonal antibodies are some examples of biotechnologies that provided an exponential growth in developing bio-therapeutics or biopharmaceuticals. In 2003, for the first time in history, the United States Food and Drug Administration is on its way to approve more drugs of biotechnology products than drugs derived from small chemical candidates. This chapter defines biotechnology from the perspective of developing pharmaceuticals, followed by a brief overview of developing biopharmaceuticals and the unique aspects of how the macromolecules are defined and used as therapeutics. Topics include (1) consideration of biotechnology versus pharmaceutical biotechnology, (2) a brief review of a historical perspective of pharmaceutical biotechnology, and (3) revealing (highlighting) the fact that drugs and vaccines that carry the same name are not identical. For example, exchanging the methyl side chain with the carboxylic group of a now defunct antihistamine drug, terfenadine (Seldane) has given rise to a much safer antihistamine drug fexofenadine (Allegra). In contrast, altering amino acid residue(s) on protein pharmaceuticals such as insulin derivatives—i.e., insulin-lispro, insulin-aspart, insulin-glargine, insulin-beef, and insulin-pork—do not yield new drugs. All these derivatives are still known as insulin and used to regulate blood glucose levels in diabetes (albeit at different dose and dosing intervals). Clearly, not all protein drugs and vaccines of the same name are identical. This chapter defines the terms biopharmaceutical and pharmaceutical technology, and points out the disparity in naming conventions of biopharmaceutical and classical drugs.