Issue 1 - the Research Centre Page

The Research Centre Newsletter Issue No. 1 | April, 2012
Radiopharmaceuticals at KFSH&RC:
Past, Present and the Future
manhar vora, phd
the past:
Push time clock back to late seventies. Now imagine
founders of the KFSH&RC laying the foundation for
what was then the Cancer Therapy Institute (CTI).
Also, imagine their vision to think futuristically
when even many developed countries did not have
the advanced technology that was being initiated at
KFSH&RC in form of indigenous manufacturing of
radiopharmaceuticals for advanced practice of nuclear
medicine. Imagine further the highly energetic
and charged protons zipping in a circular path inside
of a particle accelerator (the cyclotron) at one third
the speed of light, and crashing into the nucleus of a
targeted atom. Immediately, as a result of high energy
collision, nuclear reaction(s) occur on impact, transforming
a non-radioactive atom into a radioactive one.
Moreover, the carefully chosen target atom becomes
clinically useful radionuclide (radioisotope), and subsequently
a radiopharmaceutical.
What is a cyclotron and what are radiopharmaceuticals
you may ask? Simply put, radiopharmaceuticals are
the drug products that are characterized by presence
of radioactive element in the core of their molecular
structure. And, among these are the products that are
manufactured only in a cyclotron. Cyclotron, on the
other hand, is a particle accelerator that can accelerate
at high speed the small particles such as a proton that
becomes energetic enough to cause nuclear reactions
to produce radioisotopes.
radioPharmaceuticals produced by the CRD
the present:
Now fast forward by three decades. Turn your attention
to the far end of Research Center, and you will
see a new building. It’s the new home for a shiny new
state-of-the-art cyclotron, and all that one would need
for manufacturing comprehensive range of radiopharmaceuticals.
After all, it is the tradition of continuous
innovative thinking and initiatives, setting new milestones
and high standards at every turn (see the inset).
Cyclotron &Radiopharmaceuticals Department Milestones
1979 First Cyclotron (proton, deuteron, alpha and helium
particles) arrived on site
1982 First proton beam generated for manufacturing radioisotopes
1983 First radiopharmaceutical produced for patient use
1984 First Positron camera (PC-4200) installed
1991 Patent for manufacturing Iodine-124 radioisotope
1994 First PET Scanner installed
1995 First volunteer imaging with PET using 2-FDG PET
Radiopharmaceutical
2001 ISO 9001:2000 certification (Quality Management)
2005 Second cyclotron installed (11 MeV proton energy)
2010 Third cyclotron installed (30 MeV proton energy)
2011 Commissioning of Mo-99/Tc-99m generators production
facility
2011 Increased level of automation in production line
2011 New product line (Tc-Generator cold kits) installed
Among the radiopharmaceuticals are a special group
of products called positron emitters. Radiopharmaceuticals
derived from these isotopes are the key elements
in development of the ultra-modern imaging modalities
of Positron Emission Tomography (PET)/CT and
PET/MRI. It is interesting to note that while these
modalities are now wave of the present and the future;
these were already a past at KFSH&RC. This is yet
another example of KFSH&RC’s exemplary leadership
and the pioneering spirit.
The Cyclotron and Radiopharmaceuticals Department
(C&R Department) in the Research Center, is the proud
owner of the tradition (and of course the cyclotrons). It
is the only facility in the Gulf region that manufactures
and distributes a comprehensive range of cyclotronproduced
radiopharmaceuticals to nuclear medicine
facilities throughout the Kingdom. In this regard, you
may say C&RD facility is essentially a small scale semicommercial
pharmaceuticals industry, not only serving
the patients, but also generating significant revenues.
The first batch of radiopharmaceutical for patient use
was manufactured in 1983, and the program has not
looked back since. With continuous growth over the
years, our products are now distributed to 40 nuclear
medicine centers within the Kingdom. To date, C&RD
has supplied over 300,000 unit doses of various
radiopharmaceuticals generating revenues of over 120
Million Saudi Riyals (see the graph).
16,000,000
14,000,000
12,000,000
10,000,000
8,000,000
6,000,000
4,000,000
2,000,000
0
KFSH&RC OTHER HOSPITALS TOTAL
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
REVENUES GENERATED 1983-2011
An extraordinary aspect of C&RD’s radiopharma-ceuticals
manufacturing program is the quality of products,
which is clearly reflected in the zero incidence of
untoward reaction to the patients. Such lofty claim is a
result of judicious application of international standard
of Good Manufacturing Practices (GMP) and the ISO
quality management system during manufacturing
processes.
The credit for the high quality belongs to the people
who are in the midst of it all, and are committed to
deliver the best. The C&RD staff, from top to bottom,
makes exceptional contribution in attaining the high
standard of operations. Furthermore, routine manufacturing
is ably supported by research and development
projects. Our engineers, chemists and pharmacists
working from as early as 3 am to as late as 8 pm strive
to do all that is required to live up to the C&RD motto
of product delivery “on time, every time”.
Cyclone 30
Three decades of experience and the high standard of
operations has created experts within the C&R Department
who are sought after nationally by the future
Cyclotron/PET facilities and internationally by the
International Atomic Energy Agency (IAEA, Vienna)
for sharing their knowledge as expert advisors and consultants.
Consequently, our senior staff are recruited
for field missions as far as Brazil and South Africa, and
have co-authored a number of books on the subject of
radioisotopes.
the future:
Now imagine making the Kingdom self-sufficient in
better than 90% of all its radiopharmaceutical needs.
Not only that, imagine sufficient capacity to market our
products to NM facilities in Gulf Region and perhaps
beyond. That’s the one ultimate goal set by the C&R
Department for the future.
This is not just imagination! The monumental effort of
the Cyclotron Facility Expansion Project is the culmination
of yet another dream and vision of the Research
Center, Hospital and the Kingdom, and we could not
be more proud of what has been achieved. It is after 33
years of the initial installation that a facility is recreated
to last perhaps another generation.
KFSH&RC was unique three decades ago in a number
of ways, not the least in establishment of a medical
cyclotron at the time when there were only a handful of
such facilities worldwide. The tradition continues even
today as KFSH&RC remains one of the handful medical
centers in the world with a comprehensive program
of radiopharmaceuticals manufacturing.
It does not take much imagination that success follows
naturally when there is commitment and application at
all levels. The future is already here!
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