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The pharmaceutical industry's processes for drug development
and manufacturing are in a time of extraordinary transition, characterized
by new drug leads, new markets, new models, new instrumentation,
new processes, and increasing regulatory constraints. There is
an expanding and critical need to keep pace and to generate new
knowledge, which will improve efficiencies in these areas. Furthermore,
the supply of new personnel educated in Pharmaceutical Technology
is expected to, at best, remain steady. Purdue University sees
this situation as an opportunity for growth in the areas of our
existing core competencies and beyond. We would like to expand
research and education in manufacturing science, advanced manufacturing,
Process Analytical Technology (PAT), sensor-based analysis, modeling,
informatics, biomaterials, formulation design, Good Manufacturing
Practices (GMP), and regulatory affairs.
In addition, the manufacture of orphan and legacy drugs is a problem
for many pharmaceutical companies. The market for any single orphan
drug is not big enough to be profitable for companies like Eli
Lilly. Thus, there is a gap between the worldwide demand and supply
of these critical drugs. The gap in providing these medicines
has left many patients, both foreign and domestic, struggling
to obtain an important element of their healthcare. It would thus
make sense if reliable partners who are not involved in drug discovery
could share or take over the responsibility of continuing with
manufacturing these orphan drugs. However, developing reliable
& cost-effective processes to manufacture these orphan drugs
is not enough. There is a need to train the pharmaceutical professionals
in developing countries like India, China and Russia in GMP regulations
and practices to manufacture these drugs. Only then can we be
assured that these countries will safely manufacture these orphan
drugs for patients in their countries
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