Cyclotek (Aust) Pty Ltd Radiopharmaceuticals for Positron Emission Tomography (PET)
Cyclotek operates the first commercial medical cyclotron facility in Australia. From the operations centre in Melbourne, it has the capacity to supply Positron Emission Tomography (PET) radiopharmaceuticals throughout Australia and New Zealand.
A second facility is being established in Sydney, to increase capacity and provide redundancy. Another facility is under construction in New Zealand. Cyclotek is the largest supplier of the most widely used PET radiotracer, Fluorodeoxyglucose (FDG) in the region.
During 2008/2009, Cyclotek will be releasing a number of new PET radiopharmaceuticals, including those that target protein synthesis, hypoxia and cell proliferation.
Main business focus/
Listing by sector:
- Medical Devices - Diagnostic Imaging & therapeutic radiation devices
- Drug Discovery & Development
- Clinical Trials
As an independent company, Cyclotek has the flexibility to respond quickly to market and clinical needs, and to engage in R&D projects and collaborations that are leading to availability of novel PET radiopharmaceuticals, and development of new synthesis and labelling methods and equipment. The facility is based on the latest cyclotrons and equipment, is fully compliant with GMP and licensed by the Australian Therapeutic Goods Administration (TGA).
Cyclotek concentrates on yield optimization of promising novel radiopharmaceuticals, so that these can be made available in quantities sufficient for routine clinical use.
Cyclotek has the capacity to manufacture under contract PET radiopharmaceuticals for research and clinical trials. In particular, radiopharmaceuticals for use in Phase II/III trials need to be manufactured under GMP.
By providing this service, Cyclotek can facilitate multi-centre clinical trials in Australia involving the use of such radiopharmaceuticals.
Cyclotek operates dedicated production and QC facilities for investigational products. The capacity exists to:
- Implement client’s synthesis and radiolabelling protocols on existing synthesis modules at Cyclotek,
- Accommodate client’s proprietary modules in dedicated hotcells for the duration of the trial,
- Provide complete regulatory framework, including development of Standard Operating Procedures, Validation and QC protocols specific to the product,
- Manufacture and distribute the product throughout Australia and New Zealand.
On completion of trials, Cyclotek can offer contract or licensed manufacture of commercial product.
- Cyclotrons and radiochemistry facilities to GMP standard
- Full service, including microbiology and endotoxin testing
- In-house design and engineering of radiochemistry equipment
- Regulatory affairs and protocols capability
Cyclotek is involved in a number of ventures and collaborations with the Australian Nuclear Science and Technology Organisation (ANSTO), Universities and Medical Research Institutes, and Industry Partners that are leading to development and optimisation of a broad range of novel radiotracers.
Cyclotek was also a lead organisation in the successful bid to establish the Cooperative Research Centre (CRC) for Biomedical Imaging Development (http://www.crcbid.com.au) with the following participants: ANSTO; Berthold Australia; Garvan Institute; GE Healthcare; IBM Australia; Monash University; Peter MacCallum Cancer Institute. Cyclotek also has access through a sister company to clinical (human) and preclinical (small and large animal) imaging facilities that include PET, MRI, and CT.
Pharmaceutical and Biotechnology companies with novel PET radiopharmaceuticals, requiring access to GMP compliant manufacturing sites in Australia and New Zealand for clinical trials.
|Contact person||David Krenus|
|Address||38 Clements Avenue,|
|Phone||+61 3 9467 4966|
|Fax||+61 3 9467 6033|