Large molecule drug manufacture

There are distinct differences in the manufacture of small and large molecule drugs the former is mainly based on organic chemical synthesis, while the latter relies on biological systems of recombinant DNA (rDNA) technology. In this chapter, we describe the manufacturing processes for these drugs under GMP environments. 

A large drug manufacturer has decided to study this molecule and formulate it into a drug if it proves to be safe and effective. As an aside, the San Bushmen of the Kalahari desert are currently impoverished and oppressed. If P57 becomes a money-making drug in developed countries, it may mean a better life for people of this tribe, since they will receive royalties (money) when the drug is sold. This drug is very early in the research process and it will be several years before it could be available in the United States. 

On a global level, GMP regulations are very similar for various countries. There are, however, differences in emphasis and implementation in specific areas. We will explain the GMP regulations from the United States, Europe, and the International Conference on Harmonization (ICH) in this chapter. In Chapter 10, we will discuss the manufacturing processes for small molecule synthetic and large molecule protein-based drugs. 

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