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Cyclotek and ANSTO to manufacture new radiopharmaceuticals

Manufacturing News

Cyclotek and ANSTO have announced the launch of a Joint Venture to establish Australia’s first GMP (Good Manufacturing Practice) theranostics production facility which will produce radiopharmaceuticals for both the diagnosis and treatment of cancer.

The new company Applied Molecular Therapies Pty Ltd (AMT) will aim to establish a Therapeutic Goods Administration (TGA) approved, GMP manufacturing capability in Melbourne for a range of radiopharmaceutical therapies, initially focused on use of the radionuclide Lutetium-177.

Cyclotek CEO Greg Santamaria said “This new organisation will lead, for Australia, development of a local research and manufacturing base to secure supply of targeted radiopharmaceuticals, with our stated aim of improving cancer patient outcomes with accessible, targeted radiopharmaceuticals.”

“This is an exciting development for cancer treatment.”

The two businesses are already key producers of radionucleatides – substances that emit radiation to treat disease, but which must in many cases must be made onshore because of their short half-lives.

ANSTO operates Australia’s OPAL nuclear reactor at Lucas Heights in Sydney, while Cyclotek operates two cyclotrons at it’s main facility in Bundoora, Victoria.

The announcement was made at the National Theranostics Roundtable 2021 – The Future of Precision Oncology in Nuclear Medicine.

The last decade has seen the emergence of new and promising radionuclides primarily for therapeutic applications.

Globally n.c.a. Lutetium-177 is the preferred radionuclide for clinical development due to its high level of radionuclidic purity and the absence of the metastable Lutetium-177m – which has a 160 day half-life – thereby circumventing the cost of clinical disposal management.

Santamaria said: “Our aim is for the Lutetium-based radiopharmaceuticals to be fully compliant with Australia’s regulatory frameworks for clinical trials and Special Access Scheme for compassionate use.

“Patients and clinicians can rest assured that our products will meet all the safety and quality standards expected of a radionuclide therapy,”

Picture: ANSTO

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