Radiopharmaceuticals overview of requirements

Transcription

1 Radiopharmaceuticals overview of requirements

2 Did you know? That Australia has a research nuclear reactor producing nuclear medicine 1 in 2 Australians will receive some kind of nuclear medicine in their lifetime Diagnostic Treatment

3 Who is ANSTO Australian Nuclear Science and Technology Organisation Part of Dept of Industry, Innovation, Science, Research and Tertiary Education Managed by a Board There are 4 strategic directions: Delivery world class research and innovation in nuclear science and technology Expand ANSTO s reach and contribution, exploiting landmark technologies Serve the nuclear needs of the government, industry, community and people of Australia Drive organisational renewal A key objective for ANSTO is the manufacture & supply of radiopharmaceuticals for Australians There are a number of key divisions at ANSTO OPAL- Australia s research reactor ANSTO Health providing radiopharmaceuticals Research Divisions and Operating Divisions

4 Who is ANSTO Health ANSTO Health is a commercial supplier of radiopharmaceuticals to public & private nuclear medicine centres. 90% Medical Diagnostic & 10% Medical Therapeutics Servicing around 230 NM Centres in Australia & NZ Exporting to a number of countries in the Asia-Pacific region including: China, Hong Kong, Indonesia, Korea, Malaysia, Myanmar, New Zealand, Philippines, Singapore, Taiwan & Thailand. Export contract manufactured product to USA & Europe 80% Domestic & 20% Export

5 ANSTO Health Products include Reactor Based Products: Gentech Generator (Tc-99/Mo-99) Chromium 51 Iodine 131 Samarium 153 Yttrium 90 (under contract) Cyclotron Based Products Iodine 123 (bulk imported) Products can be used in their bulk form or are bound with another material Reactor produced isotopes are used in ~ 470,000 diagnostic procedures in Australia each year. Cyclotron based products/radioisotopes account for ~90,000 procedures. FDG (F18) now main cyclotron products manufactured by a number of organisations, not ANSTO Health

6 How the product makes it to the patient U 235 in reactor for irradiation Mo-99 Separated Tc-99m Generator Transport & Dispensing Patient days 7 days 2 days 1 day 1-2 days

7 How do standards apply Commercial radiopharmaceutical production: Requires GMP licence Many of the products are sterile injectibles GMP Codes Part 1 and 2 apply Dependent if finished product or the bulk Annex 3 specific to radiopharmaceuticals Stability is a requirement No different to many other organisations

8 Stability Like many organisations stability is a journey An interesting one when: You know by chemistry and physics of the decay What you have now you don t have tomorrow Half lives that vary from minutes (112 for F18) to days (27 for Cr51) Have short times for testing and release Limited capacity for safety reasons

9 The journey Long term stability program Now considers what is stability indicating rather than testing all specifications What have we learnt Radionuclidic purity Specific activity Radiochemical purity ph changes Preservative testing Radioactive content

10 We test past current expiry Grandfathered products limited new products Bracketing and planning The journey cont. (2) Some samples are not safe to test due to the amount of dose May look at a lower dose sample Is it safe to sample the study with other activity Facility capacity Issue of stabiliser / not stabilised Interactions with the container Example bulk export of Mo99

11 The journey cont (3) Customer requirements Critical link to change control eg different vials How the customer uses the product Contract manufacturing Who is responsible for the stability Make sure it is documented and understood Cold kits Stability of the product itself Stability when used with the material

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13 Thank you