INTRODUCTION
Biotechnology has been defined in many different ways. Specific
definitions for pharmaceutical biotech-nology can be deduced directly from
these definitions. In general biotechnology implies the use of micro-organisms,
plants, and animals or parts thereof for the production of useful compounds.
Consequently, pharmaceutical biotechnology should be considered as
biotechnological manufacturing of pharmaceutical products.
Biotechnology has been defined in many different ways. Specific
definitions for pharmaceutical biotech-nology can be deduced directly from
these definitions. In general biotechnology implies the use of micro-organisms,
plants, and animals or parts thereof for the production of useful compounds.
Consequently, pharmaceutical biotechnology should be considered as
biotechnological manufacturing of pharmaceutical products.
Insight into the nature of the traditional processes was achieved about
1870 when Pasteur made clear that chemical conversions in these processes are
performed by living cells and should thus be considered as biochemical
conversions. Biotechnology became science! In the decades after Pasteur
knowledge in-creased when the role of enzymes as catalysts for most of the
biochemical conversions became apparent. Based on that knowledge, tools became
available to control and optimize the traditional processes to a certain extent.
A further and very important breakthrough took place after the
development of molecular biology. The notion, brought forward by the pioneers
in molecular biology around 1950, that DNA encodes proteins and in this way
controls all cellular processes was the impetus for a new period in
biotechnology. The fast evolving DNA technologies, after the development of the
recombinant DNA technology in the seventies, allowed biotechnologists to
control gene expression in the organisms used for biotechnological manufactur-ing.
Moreover, the developed technologies opened ways to introduce foreign DNA into
all kinds of organisms. As will be shown later, genetically modified organisms
constructed in that way opened up complete new possibilities for biotechnology.
Thenew form of biotechnology, based on profound knowledge of the DNA molecule
and the availability of manipulation technologies of DNA, is frequently
described as “molecular biotechnology.” The possibi-lities of the molecular
approaches for further devel-opment of biotechnology were immediately apparent,
albeit that the expectations sometimes were over-estimated. At the same time
biotechnology became the subject of public debate. An important question in the
debate deals with potential risks: Do genetically modified organisms as used in
production facilities pose unknown risks for an ecosystem and for the human
race itself? Moreover, a profound ethical question was brought forward: Is it
right to modify the genetic structure of living organisms?
In this chapter we will focus mainly on the new biotechnology by
describing its means and goals. As to the question concerning potential risks
of the technology, we will confine ourselves to stating that all sorts of
measurements are taken to avoid risks while using genetically modified
organisms. The ethical aspects, interesting as they are, are beyond the scope
of this chapter.
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