Chapter 1 Introduction
Commercial production of products produced by genetically engineered microorganisms requires two distinct body of knowledge, namely, molecular biology and process engineering. Background in molecular biology will enable us to create effectively expressed genes in microorganisms or cells of animal, insect or plant origin that can be used for industrial production. Background in process engineering principles wil enable us to design and operate large-scale plants for growing genetically-engineered organisms and for the subsequent processing of purification and formulation of product. In the early days, it was thought that scale-up was simply a matter of using larger volumes. That is, conditions that were found to be good at a small-scale would be equally effective on a larger scale and that to achieve this it was merely necessary to use a larger fermentor vessel with a larger medium volume. Such an approach resulted in not only product variability, both in terms of yield and quality, but also expensive operating costs. Hence, a systematic study of process engineering principles is needed for scaling up and operation of biotechnological processes for manufacture.
In this chapter you were introduced to main componenets of a biopharmaceutical manufacturing facility, and specifically issues concerning bioreactors. In the chapters following, we will learn how to determine material need of a bioreactor.