Cyclotek is currently engaged to manufacture PET tracers for clinical trials relating to:
- Alzheimer’s
- Parkinson Disease
- Multiple Sclerosis
- Prostate Cancer
- Melanoma
- Brain tumours, etc
Cyclotek has the capacity to manufacture PET radiopharmaceuticals for research and clinical trials under contract; in particular, radiopharmaceuticals for use in Phase II/III trials manufactured under GMP.
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.
