What is the ANSTO Nuclear Medicine Project?
In 2012 the Australian Government announced a $168.8 million investment that will position Australia as a global leader in the manufacture of nuclear medicine and secure the long term sustainability of nuclear medicine supply in Australia.
The project includes an export scale Mo-99 Manufacturing Facility and an innovative ANSTO Synroc waste treatment plant. Both of these new facilities will be owned and operated by ANSTO Nuclear Medicine (ANM) Pty Ltd, a majority subsidiary of ANSTO.
The new Mo-99 Manufacturing Facility will enable ANSTO to triple production of Molybdenum-99 (Mo-99). The increased capacity will enable Australia to meet domestic demand, as well as being able to supply up to 25% of global demand. Used for 80 per cent of nuclear medicines, Mo-99 is the base material used in the diagnosis of cancers, heart disease, muscular and skeletal conditions.
Early in 2019, ANSTO's new Mo-99 Manufacturing Facility entered a 'transition phase', the final operational phase moving from sample production runs to commercial supply.
Before the facility can commence normal operation, it requires regulatory approval from both ARPANSA (from a safety perspective) and health regulators such as the TGA (from a product quality perspective).
Whilst the facility and production team are operationally ready, the various regulatory bodies have careful review processes to carry out in order to provide approval to ANM Pty Ltd for the supply of Mo-99.
ANM was granted an operational licence by ARPANSA in August 2018, subject to the successful completion of “hot” commissioning and the fulfilment of a number of licence conditions. Whilst relevant information has been supplied to ARPANSA, we are currently in dialogue with them regarding some requests for further information. Formal approval to move into commercial operation is not expected until the end of March.
In terms of medical regulatory approval, ANM is working with both domestic and international customers to support applications to the relevant regulatory bodies which will allow supply to commence. It is anticipated that approval will be received for domestic supply before it is received for international supply.
The Australian Government committed $168.8 million investment for the ANM project
Siting licence granted from ARPANSA
Approval granted by Department of Sustainability, Environment, Water, Population and Communities
Public Works Committee approval received
Licence issued for construction of both the Mo-99 Manufacturing facility and the co-located ANSTO Synroc waste treatment plant
Contract to design and construct the new Mo-99 Manufacturing Facility awarded to Watpac Limited
Construction of Mo-99 Manufacturing Facility commenced
Practical completion of the Mo-99 Manufacturing Facility was achieved late in 2017
Cold commissioning successfully completed
Hot commissioning successfully completed
Construction of ANSTO Synroc waste treatment facility commenced
ARPANSA granted an operational license to the Mo-99 Manufacturing Facility late in 2018
Mo-99 Manufacturing Facility moved into the ‘transition phase’ carrying out batch runs of product to support domestic and international customers in their applications to relevant regulatory bodies
Domestic commercial supply expected to commence in April - May 2019
International commercial supply expected to commence in the second half of 2019
ANM Board of Directors
The ANM Board of Directors provide governance and strategic direction for the project and work effectively with senior management to ensure the delivery of the project. The Board of Directors bring a wealth of knowledge and expertise from within the nuclear science and nuclear medicine industry.
Con Lyras, Chair