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   4. Primary manufacture
Photo of fermentation vessel
Picture 4.1 Inspecting a fermentation vessel used in the manufacture of a medicine
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 in the 1930s. More recently, scientists have modified the genes of bacteria so that they can produce useful proteins. By the early 1980s, there were bacteria making human insulin and human growth hormone. We call this technique genetic engineering.
Genetic engineering
Genetic engineering allows scientists to introduce 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.
Making biopharmaceuticals
The production of biopharmaceuticals is similar to the primary manufacture sequence on page 8. 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 vials as a solution or as a freeze dried powder. It is then ready to be formulated in secondary manufacture.

The Human Genome Project is the enormous job of mapping the complete Human Gene. It is changing our understanding of diseases and their causes. Most importantly, with the help of biotechnology, it may allow us to cure them.
Using the active ingredient
The active ingredient is the output of the primary manufacturing stage. However, it is not in a suitable form to give to a patient. It has to be turned into a medicine. This is done in secondary manufacture.

Flow diagram

This flow diagram shows the secondary manufacture of tablets. A range of different medicines can be made in secondary manufacture (see page 2).

You can find out more about secondary manufacture in the next chapter.
Question 7

a) What do we mean by the term biotechnology?

Meaning Phrase
b)  What was the first medicine to be produced using biotechnology?
(use small letters and be careful with your spelling)
c)  For each of these descriptions, decide whether it is an input, a process or an output.
i. fermentation
ii.  a growth of a fungus
iii.  a strain of genetically modified bacteria
iv. insulin produced by bacteria