Types of Recombinant Drugs - Biotechnology and Your Health: Pharmaceutical Applications - page 60

CONNECTIONS
In 1982, the FDA approved human insulin made in E. coli , the first
recombinant protein drug to gain approval. Since then, biotech-
nology has provided more than 90 new medications and many
diagnostic laboratory tests using these basic building blocks, tools,
and tricks. But producing a protein drug is far from a sure thing.
When scientists propose that a recombinant protein may be useful
for preventing, treating, or diagnosing a disease, the challenge is to
find a way (through both established and new molecular biology
methods) to produce a protein economically and to show that
the drug has the desired effect on cells in laboratory and animal
tests. Many months of experiments are required to develop a cost-
effective, reliable, and safe production method. Sometimes new
factories must be built just to perform these experiments. The FDA
also requires drug manufacturers to show that any drug produced
is free of potentially harmful contaminants. Only then may human
trials begin to test whether the drug is safe and effective. Because
biotechnology drugs are produced from living organisms, special
steps must be taken to show that the FDA's standards for purity and
safety have been met. Biotechnology drugs can be more expensive
to make than conventional drugs synthesized in the laboratory
from simple chemicals because of the time, effort, and costs of
developing the production process, creating large amounts of
a protein drug and meeting FDA requirements. Biotechnology
drugs, however, may provide treatments that would not otherwise
be available and in some cases may provide life-saving options.
FOR MORE INFORMATION
For more information about the concepts discussed in this chapter,
search the Web using the keywords:
monoclonal antibodies , bacterial transformation , transfection of cells