ABSTRACT
A biopharmaceutical is a drug product that is produced from living sources such as cells or tissues. Also known as biologics, biopharmaceutical products include not only recombinant therapeutic proteins but also naturally sourced proteins, live virus vaccines, and blood components. The discovery of penicillin in 1920 led to the first biopharmaceutical product. However, it was not until the creation of recombinant technology that production of therapeutic proteins in a laboratory setting became possible. The first boom in the discovery and production of biopharmaceuticals took place in the 1980s, as evidenced by the approval and marketing of recombinant human insulin, human growth hormone, interferon gamma, and other important therapeutic molecules. Leveraging the advances in cellular and molecular sciences and technologies, biopharmaceutical firms have been able to develop targeted therapies for treating diseases ranging from cancers to rare genetic disorders. As of 2014, more than 300 biopharmaceuticals have been approved for marketing. The biopharmaceutical industry clearly has become one of the fastest-growing sectors. At present, there are more than 900 biopharmaceutical molecules in various stages of development for the treatment and prevention of a wide range of diseases. With some older biologics coming off patent, biosimilar product development has emerged as a nascent and rapid growing area as well. However, chemistry, manufacturing, and control (CMC) issues present a host of unique challenges in the development of biopharmaceutical products.
