Chapter 2: Biopharmaceutical Proteins: The Manufacturing Challenge

The biopharmaceutical industry is one of global importance and has driven the growth of the pharmaceutical industry over the last 20 years. This industry is responsible for the production of medicinal products manufactured in, extracted from, or semi-synthesised from biological sources. It has supplied innovative medicines to treat some of the most serious and debilitating diseases where conventional pharmaceuticals have proven ineffective. However, the development of the industry has not been easy and has relied on multiple advances in biology, biotechnology, analytical science and engineering. By making use of a broad range of technologies it is now possible to develop and manufacture highly complex biopharmaceuticals in an efficient, robust and economic manner. This chapter focuses on biopharmaceutical proteins, which are a key component in healthcare today. Their success would not have been possible without major developments in technology to manufacture them. Here we look at the manufacturing challenges and the techniques developed to make and purify proteins from a range of different types of organism. Such manufacturing technology, as we shall see, is now facing new hurdles with the increasing need to reduce the costs of healthcare and demand for more lower-priced drugs and more sophisticated and effective treatments with higher quality.