Contract Manufacturing

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.