| THE GLOBAL INDUSTRY
According to research conducted
within the global pharmaceutical industry,
the development of a drug requires
an investment of $1 billion and a
development period of 10-15 years. The
same statistics also highlight that 80-85
per cent of these drugs fail at human trial
stage, wasting billions of dollars and manhours
each year. As a result, a monopoly
has been created with only the larger
industrial houses having the resources
and funding available to bring drugs to
market. Over the past five to 10 years,
there has been significant growth in the
development of biological molecules
for human medicinal use.
As traditional
small molecule ‘blockbuster’ drugs
are becoming harder to identify, and
scientists’ understanding of how drugs
work at a molecular level within the
body has increased, drug manufacturers
have recognised the importance of
offering aseptic filling using isolator
technology, for both quality standards
and economic purposes.
THE POSITIVES
The use of sealed gas isolators provides
the highest form of protection for aseptic
products and has also shown to provide
a higher level of sterility assurance than
traditional aseptic process filling. This is
because human borne contamination is
eliminated within the isolator. In addition,
reproducible biological decontamination
can be delivered to all of the exposed
surfaces inside the isolator. |
