Ch. 4— The Pharmaceutical Industry • 63 
Figure 21.— The Product Development Process for Genetically Engineered Pharmaceuticals 
Micro-organisms such as E. coll 
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19. Submit IND 
The development process begins by obtaining DNA either through organic synthesis (1) or derived from biological sources such as tissues 
(2). The DNA obtained from one or both sources is tailored to form the basic “gene" (3) which contains the genetic information to “code" for a 
desired product, such as human interferon or human insulin. Control signals (4) containing plasmids (6) are isolated from micro-organisms such 
as E. coir, cut open (7) and spliced back (8) together with genes and control signals to form "recombinant DNA" molecules. These molecules are 
then introduced into a host cell (9). 
Each plasmid is copied many times in a cell (10). Each cell then translates the information contained in these plasmids into the desired pro- 
duct. a process called "expression" (11). Cells divide (12) and pass on to their offspring the same genetic information contained in the parent 
cell. 
Fermentation of large populations of genetically engineered micro-organisms is first done in shaker flasks (13), and then in small fermenters 
(14) to determine growth conditions, and eventually in larger fermentation tanks (15). Cellular extract obtained from the fermentation process is 
then separated, purified (16), and packaged (17) for health care applications. 
Health care products are first tested in animal studies (18) to demonstrate a product’s pharmacological activity and safety. In the United 
States, an investigational new drug application (19) is submitted to begin human clinical trials to establish safety and efficacy. Following 
clinical testing (20), a new drug application (NDA) (21) is filed with the Food and Drug Administration (FDA). When the NDA has been reviewed 
and approved by the FDA the product may be marketed in the United States (22). 
SOURCE; Genentech. Inc. 
