The Pharmaceutical Business   5 of 13  
     2. Making pharmaceuticals
Flowchart
Figure 13. The different stages in the Primary manufacture and secondary manufacture of tablets.
Figure 13 shows the production process at a major UK pharmaceutical manufacturer - Pillco. The active ingredient is made in primary manufacture and it is formulated in secondary manufacture.

Primary manufacture. This is a simple example of and primary manufacture. In this case, two chemicals are reacted together to make the active ingredient. Often, there will be more chemicals and more steps to this initial reaction. The active ingredient is then purified, dried and milled. It is now ready to pass on to the secondary manufacture.

Secondary manufacture. In this example, the active ingredient is put into tablets. It is mixed with excipients, which give the tablet bulk and can help to control the release of the active ingredient. For other medicines, the active ingredient would be mixed with different excipients to make capsules, solutions, creams or sprays.
Biotechnology
We can define biotechnology as the industrial use of biological material. This means that living materials are used in the manufacture of ingredients. It started when penicillin was extracted from the mould Penicillium notatum. More recently, scientists have modified the genes of bacteria so that they can produce useful proteins. We call this technique genetic engineering. By the early 1980s, there were bacteria making human insulin and human growth hormone.

The basic method of genetic engineering involves introducing new genes for useful proteins into the DNA of cells. The cells may be bacteria, fungi or cultures of animal cells. The modified cells can be grown on a large scale to produce proteins in industrial quantities. These products are called biopharmaceuticals. They can be vaccines, hormones, enzymes or monoclonal antibodies. Monoclonal antibodies help to prevent rejection of transplants and can treat and diagnose some cancers.
Photo of fermenter
Figure 14. Biotechnology provides a powerful resource for the modern pharmaceutical industry.
Making biopharmaceuticals
The production of biopharmaceuticals is similar to the primary manufacture sequence in picture 13. The raw materials are usually the cells or micro-organisms and the culture medium in which they grow. The reactor is usually a fermenter where conditions are carefully controlled to optimise activity. The product is extracted using a series of filters and centrifuges and purified by chromatography. The active ingredient is usually provided in solution. This then goes into secondary manufacture where it is formulated. It is usually inserted into vials as a solution or a freeze dried powder.

The Human Genome Project is the enormous job of mapping the complete human genetic code. It is changing our understanding of diseases and their causes. Most importantly, with the help of biotechnology, it may allow us to cure them.