01 RADIOPHARMACEUTICALS

PRODUCTION
The Cyclotron an d R adioph arm ace u t ic a l s De-
par tment boast s of a st ate -of-t h e -art fa c i l i ty
for the pro du ct ion of radioph arm ace uti c a l s o f
the highest qu alit y an d con siste n cy.

Radioisotopes of high activity CURRENT SPECT/THERAPEUTIC

are handled and processed in PRODUCT LINE
heavily-shielded “hot cells” equi-
ped with master-slave manipula- 67Ga
► Gallium-67 Citrate Injection.
tors to ensure protection of staff
201Tl
from radiation exposure. ► Thallium-201 Chloride Injection.
131I
► Sodium Iodide Capsules (Diag-
Sterile radiopharmaceuticals nostic).
are produced aseptically in ► Sodium Iodide 131I Capsules (Thera-
controlled clean areas to ensure peutic).
safety and sterility of the prod- 131I
► Sodium Iodide Solution (Diag-
uct.
nostic).
Strict adherence to Good Man- 131I
► Sodium Iodide Solution (Thera-
ufacturing Practices ensures
peutic).
product of the highest quality.
► mIBG (Iobenguane) 131I Injection
(Diagnostic).
Standard Operating Procedures
131I
► mIBG (Iobenguane) Injection
define each production process,
thus ensuring product of consis- (Therapeutic).
123I
tent quality with a high success ► Sodium Iodide Capsules.
123I
rate. ► Sodium Iodide Solution.
123I
► mIBG (Iobenguane) Injection.
123I
► OIH (O-Iodohippurate) Injection.
► 81Rb/ 81Kr Gas Generator.

► State-of-the-art production facility. ► Started with introduction of four

► Controlled clean areas for aseptic production. radiopharmaceutical products in 1983.
► Adherence to Good Manufacturing Practices. ► Twenty three additional radiophar-
maceutical products introduced in the
► Processes defined by Standard Operating
Procedures. last 30 years.

1 978 1 9 82
F ir st Cyc l ot ron (C S -3 0, 26 .3 M eV) arrives at Fir st Proton beam
KFSH & R C . achieved.
 PET RADIOTRACERS PRODUCTION

02
Positron Emission Tomography (PET) for diagnosis has gained
widespread use during recent years, with 18F Fludeoxyglucose
Injection being the workhorse for PET centers worldwide. (FDG)

The Cyclotron and Radiophamaceuticals Department has increased its pro-

duction of FDG ten-fold over the last decade to cater to the ever-increasing
needs of KFSH&RC as well as several other PET centers in the Riyadh area.
Arrangements are in place to provide FDG and PET centers located as distant
as Jeddah. Currently, as many as 80 patients per day are routinely diagnosed
using FDG; plans are underway to further increase our FDG supply in the near
future.

CURRENT PET PRODUCT LINE

► 18F 2-FDG (Fludeoxyglucose) Injection. Additionally, the C&R Depart-

ment at KFSH&RC is routinely
► 18F Sodium Fluoride Injection.
producing several other PET
► 18F-Choline. radiotracers. Development
work is underway to introduce
► 18F-DOPA (Dihydroxy-6-Fluoro-L-Phenyl- several other novel PET radio-
alanine). tracers in the near future.
► 18F-FLT ( Fluorothymidine).

► 13N Ammonia Injection.

► 68GaPSMA (Prostate Specific Membrane

Antigen).

► 68Ga DOTA-TATE.

► 124I Sodium Iodide Capsules.

► 124I Sodium Iodide Solution.

► 18F-PSMA (Prostate Specific Membrane

Antigen).

► 18F-FES (Fluoroestradiol).

► 177Lu Labeled Therapeutic Products

FUTURE DEVELOPMENT

► Lyphilized Cold Kits.

► 18F
2FDG is considered the
► 68Ga Production from Cyclotron. “workhorse” of PET imaging.

► 11C Labeled Radiotracers. ► Dedicated production

facility.
► 18F FMISO (Fluoromisonidazole).
► Dedicated 11 MeV Cyclotron
► 64Cu Labeled Radiotracers. for production.
► 99Mo/ 99mTc Generators. ► Catering to PET centers in
Riyadh and beyond.
► 89Zr Labeled Radiotracers
► Several novel PET radiotra-
► An impressive range of diagnostic as well as
therapeutic agents covered. ceres in development stage.
► Several new products to be introduced in the near future.

1 983 19 8 4
F ir st Cyc l ot ron - b as ed Rad io- First p o s itro n cam era inst alled.
p h a r m a ceu t i c a l p ro d uced .
03 99m
Tc GENERTORS
PRODUCTION

99mTechnetium (99mTc) based

radiopharmaceuticals are the most
essential components for parctice
of Nuclear Medicine, representing
80-90% of all SPECT diagnostic
imaging preformed world-wide.

Typically, 99mTc-radiopharmaceuti-
cals are prepared at the site of use
by mixing an appropriate lyophilized
cold kit with the active ingredients
and 99mTc (t1\2 = 6 hours) radionu-
clide obtained from a 99Molybde-
num/99mTechnetium Generator.

For the first time in the Kingdom

of Saudi Arabia, the new facility at
KFSH&RC will be routinely manu-
facturing 99Mo/99mTc generators to
be supplied to the nuclear medicine
centers within the Kingdom and sur-
rounding countries.

The semi-automated system is

designed for manufacturing 99mTc
generators within the confines of
clean-room environment for aseptic
handling and processes.

► 99mTcGenerator is considered the “work-

horse” of diagnostic nuclear medicine.

► First facility of its kind in the Middle East.

1 995 2000
Ro u tine p rod u ction of PET ra diopha rm a- Produc ti o n o f ra d i o p ha rma ceut i c a l s
ce uticals starte d . for rea c to r- p ro d uced ra d i o i s o to p es .
04 QUALITY MANAGEMENT

Management of quality of products

manufactured in our facility is
of paramount importance. This
operational philosophy is reflected in
the establishment of a Quality Man-
agement System (QMS) derived from
the international guidelines of Good
Manufacturing Practices (GMP) and
the ISO 9001 Quality Standard.
Our quality management system
(QMS) employs a process-based
approach for all its operations to pro-
vide the assurance that all processes
are fully validated and are strictly
controlled. These standard operation
procedures (SOPs) are periodically
assessed for continued suitability.
The end result is the extraordinary
success rate of achieving consistent
high quality.

Periodic Internal and External Audits

are carried out to ensure the effec-
tive implementation of the Quality
Management System.

Moreover, routine inspections are

carried out by the local regulatory
authority to ensure the effective im-
plementation of Good Manufacturing
Practices (GMP).

Because of our customer-focused

approach, we are always striving for
continual improvement of our system
to ensure that all our customer re-
quirements are consistently met.

The well-equipped quality control

laboratory performs the quality
assessment using state-of-the-art
instrumentation and validated proce-
dures. Product is certified for patient
use only upon conformity to the
pre-established quality specifications
and evidence of adherence to GMP.

Additionally, all materials used in pro-

duction of radiopharmaceuticals are
tested to ensure suitable quality.

► ISO 9001 Certified Quality Management System.

► Process-based approach.

► Customer-focused.

► State-of-the-art Quality Control Laboratory.

2006 2 010
S e con d Cyc l ot ron Construc tion of a st ate- o f - t he- a rt ra d i o p ha r-
( Ecl i p se, 1 1 M eV ) i nstalled . m a ceutic a ls m a nufa c t uri ng fa c i l i t y.
05 RADIOPHARMACEUTICALS
MANUFACTURING
AT KFSH&RC.

Manufacturing rad io-

pharmaceuticals
is a highly specialized
undertaking, and the
Cyclotron & Radiopahr-
maceuticals Depart-
ment (C&RD) within
MlSSION The C&RD is committed to
supply radiopharmaceuticals to its cus-
tomers with a very high success rate in
terms of quality, quantity and delivery.

AMBITION The ambitious endeavor

the the Research and of making the Kingdom self-sufficient
in all its radiopharmaceuticals needs
Innovation at King entails manufacturing routinely a large
vanety of diagnostic and therapeutic
Faisal Specialist Hos- radiopharmaceuticals. This capability
is continually upgraded to cater to the
pital and Research increasing demand for volume as well
as variety.
Center (KFSH&RC) has
QUALITY The most impressive and
successfully met the the hallmark feature of this production
challenge since the first facility is the application of a robust
quality management system (ISO 900
batch manufactured in I) and continuous high standard in
products manufacturing (International
1983. and local standards of Good Manufac-
turing Practices).

DISTRIBUTION To date, over 43,300

batches of products and some 607,000
patient doses of radiopharmaceulicals
have been supplied for clinical inves-
tigations and therapy throughout the
Kingdom and abroad.

COMMITMENT Our commitment to

future growth is amply supported by
R&D activities ensuring continuous
influx of new technology and products,
and also continuous quality improve-
ments. Furthermore, our scientists are
sharing their vast experience and ex-
pertise with upcoming new cyclotron/
PET facilities worldwide in the form of
valuable advice and consultations in
radiopharmaceut1cals manufacturing.

2011 2 013
Th i rd Cyc l ot ron (Cyc lo ne 30 , 30 First time product ion of
99m
Mev ) i n st a l l ed . Tec hne t ium Generator s.
 ►

06
CUSTOMER NETWORK

Presently, the
Cyclotron & Radio­
pharmaceuticals De-
partment caters to
the radiopharrraceu-
ticals needs of some
forty-five Nuclear
Medicine Centecrs in
the region.
► Our products are
shipped on a daily
basis to some twen-
ty cites and regions
within the Kingdom.
► Plans are under-
way to expand our
customer network
to include other
Nuclear Nuclear
Medicine beyond the
Kingdom.

► Starting off modestly

in 1983, the Cyclotron &
Radio­pharmaceuticals
Department was tne first
facility of its kind in the
Middle East.

► Initialy, four radiophar-

maceutical products were
being produced, primarily
RADIOPHARMACEUTICAL to cater to the needs of
UNIT DOSES SUPPLIED King Faisal Specialist
Hospital.

► Over the years the Cy-

clotron & Radiopharma-
ceuticals Department
has introduced twenty
three additional radin-
pharrnaccutical products.

► As the demand has

increased significantly
over the years, so has our
productivity to ensure
that all radiopharmaceu-
tical requirements are
satisfactorily met.

2015 2 017
124
I n t rod uction of nove l PET Ra dio- D evelo p ment of I odine product s.
t ra ce rs.
07 CYCLOTRONS

An ess ential compon e n t for m an-

ufactur ing of SP EC T an d P ET ra-
diophar mace u t icals for diagn ost ic
imiging is a part icle acce le rator :
the cyclot ron . At C &R D, t h e first
cyclotron of 2 6 .5 M ev e n e rgy pro-
ton beam (C S-3 0 ) was in st alle d
in th ear ly e igh t ie s, an d h as be e n
employed in t h e produ ct ion of
var ious SP EC T an d P ET radio-
phar maceu t icals for ove r t h re e
dacades .

Wi t h t h e g row th o f P E T imag ing , a s eco nd

cyc l ot ron of 11 M eV energ y (RDS 111),
d ed i c ated fo r manufac turing P ET rad io nu-
c l i d es wa s i nstalled in the year 20 0 6 . This
cyc l ot ron i s in f ull o p eratio n d aily fo r the
p rod u c t i on o f p o s itro n emitters in s up p o rt
of severa l PE T/CT centers w ithin reas o n-
a b l e d i st a n ce.

In t h e yea r 2012, a cyclo tro n o f 3 0 M eV

p roton b ea m energ y (Cyc lo ne 30 ) b ec ame
op erat i on a l to aug ment the ag eing CS -3 0
cyc l ot ron . The Cyc lo ne 30 (IBA, Belg ium)
i s a va r i a b l e energ y neg ative io n machine
for t h e p roductio n o f p rimarily the S P ECT
ra d i on u c l i d es as well as the P E T rad io-
n u c l i d es . This state- o f - the- art machine
i s con f i g u red w ith three main b eam lines
a l l ow i n g l a rg e vo lume p ro d uc tio n o f the
c l i n i c a l l y u s ef ul S P ECT and P E T rad io nu-
c l i d es i n s ol id , liq uid and g as eo us state.

2018 2 02 2
68 64
Devel op m en t of G allium D evelo p ment of Cu DOTA-TATE and
p ro d u c t s . P S M A.
08
06

2022
Devel op m en t of 18 F FE S (Fluo ro estrad io l) and 18
F F-PSMA (Prost ate
S p ec i f i c M em b ra n e Antig en).