Presenter: Joseline Tan

Head of Radiopharmacy

Date: 16.11.2016

� Our team consists of 9 member of staff –Pharmacist, radiopharmaceutical scientists and technicians

� Part of Pharmacy team.

� Location: Sutton site, 1st floor.

� Undergoing major refurbishment and service expansion

� Collaboration with ICR to transform bench-top research to clinical use.

� Key roles:◦ Manufacture various diagnostic and therapeutic radiopharmaceuticals in aseptic environment

◦ Quality control testing on all radio-labelled product intend for clinical use

◦ Manufacture IMP for clinical trial use

◦ In-vitro processing of Cr-51-EDTA

� Alpha – Therapeutic e.g. Radium-223 dichloride

� Beta – Therapeutic e.g. Yttrium-90 Dotatate

� Gamma – Mainly for diagnostic purpose e.g. Technetium-99m; Iodine-123

� PET – Gallium-68 Dota-peptide

� Thyroid imaging� Bone imaging� Lung perfusion imaging� Renal & liver imaging� Myocardial perfusion� Thyroid ablation� Bone metastasis� Tumour ablation� Neuroendocrine imaging� Prostate imaging

� Generator – Elution� a long-lived parent radionuclide undergoes radioactive decay to the desired daughterradionuclide.

� Mo-99 � Tc-99m� Tc-99m get wash out by saline into a elution vial, ready for labelling.

� Given that the parent will continue to decay to produce to daughter nuclide, it is possible to re-elute the generator at intervals to extract additional aliquots of daughter nuclide.

� Contamination with unwanted radionuclides gives an unnecessary radiation to the patient

� Contamination with “unbound” radionuclides may cause uptake in the wrong organ or tissue

� Organ uptake may change within minutes of preparation

� Radionuclidic Purity

� Radiochemical Purity

� Chemical Purity e.g. Al 3+ ion test

� Particle size

� Sterility testing

� EC-20 study

� MAPPING study

� POETIC study

� I-124 MIBG study

� Radium trial

…… just to name a few

� Some radiopharmaceutical require second elution etc – advance workload planning needed

� Extra documentation and accountability log

� Stock control

� Extra resource e.g. fridge & storage

� Site limit

� Staff training

� Staffing constraint e.g QP release

� Not all diagnostic tests listed in clinical trial protocol require radiopharmacy input e.g. MUGA, bone scan etc

� If the radiopharmaceutical is an IMP, it is most likely going to involve Radiopharmacy.

Any Questions