peculiarities of radiopharmaceuticals · radiopharmaceuticals judith wagener scientist:...
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Peculiarities of
radiopharmaceuticals
Judith Wagener
Scientist: Radiochemistry
2018 PSSA Conference
22-24 June 2018, Birchwood Hotel & OR Tambo Conference Centre, Boksburg
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Interesting facts
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Radiopharmaceutical is…….
+
Radiation emitted must be easily detected by nuclear instruments
Allows for in vivo tracking
Radionuclide with emitting radiation that
is measurable
Determines organ specificity
Allows for uptake of radioactivity Must be safe and non-toxic for
human administration
Biological compound/ligand with high uptake into the
target organ
“Making the body biochemically transparent“
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Radiopharmaceutical classification
Diagnostic = imaging Therapeutic = treatment
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Radiation in context
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is sterile and pyrogen free
consists of a radionuclide with optimal properties, e.g. γ-emitter with
γ-energies between 100-250 keV for SPECT
can be easily produced, is inexpensive and readily available
should have a relatively short effective half life (balancing act)
ligand/tracer with properties that allow for specific organ targetting
significant/measurable accumulation in target organ
no pharmacological or toxic effect
Ideal diagnostic Radiopharmaceuticals
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Molecular Imaging
-rays travel from within body to outside and can then be detected and imaged
Not a static scan as for a CT- or ‘CAT-scan’
• Mostly intravenously injected
• Small chemical amounts (nanogram)
• Localises in a specific organ via a metabolic process which is then imaged at that time point or
over a time period.
• Functional information in addition to anatomy
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Radiochemistry behind radiopharmaceuticals
Radionuclide production
• Nuclear reactor
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The original 99mTc generator without shielding
Pre/post regulation aspects
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Half life of radioisotopes
Activity decreases with time therefore radioactive concentration
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Less chemical more radio
FDG mass signal undetectable
37 GBq 18F
105.8 ng 18F-FDG
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QC release timeline
• Radiochemical purity
• Chemical purity
• pH
• Bacterial endotoxins
• Filter integrity
• Half-life
• Visual inspection
Release of product for
administration before
confirmation of all
QC-tests
•Radionuclidic purity
•Residual solvents
•Sterility
production Dispatch release Pre-administration
release Post release
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Facility layout
Buffer area (1)
Production
BS
C
En
tran
ce
are
a
Equipment
airlock
RA Plenum
PSH
FC
counter
Hot ce
ll
counter
co
un
ter
Buffer area (2)
Change room
-25kPa
+25kPa
+15kPa
+10kPa
Internal PPE
External PPE
Personnel flow
Material flow
Air flow
Equipment/ instrument flow
ISO 5/6: PEC sterile area
ISO 6/7: Buffer area
ISO 7/8: Ante area
CNC 13
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Radiopharma Pharma
Clinical application Therapeutic +Diagnostic Therapeutic (pharmacologic)
Facility HVAC incl pharma + radiological requirement
Negative pressure cascade
HVAC
Positive pressure cascade
Lead shielding No shielding
Legislation SAHPRA (GMP) + Radiation safety regulation SAHPRA (GMP)
Production Small scale Large scale
Limiting shelf-life (hours to days)
Half-life dependant
Longer shelf life (days to years)
Stability of pharmaceutical
QC Physicochemical,
radionuclidic + radiochemical purity
sterility testing
Pre- and post-release testing
Physicochemical
purity
sterility testing
Pre-release testing
Packaging Licensed packaging according to “Russian-doll”
concept – impact product and environment
Approved primary and secondary
packaging - impact to the product
RSP (Radio)pharmacists / QP Radiochemist with
post graduate course in radiopharmaceuticals
– clinicial trials
Pharmacist
Radiopharma vs Pharma
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Take-home wisdom M
arie C
urie
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www.necsa.co.za
Questions?
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