Research & Development
Our Approach to Innovation
Translating Radiopharmaceutical Innovation into Patient Access
The healthcare sector is entering an era of more personalised medicine, where accurate biological imaging can help clinicians better understand disease and treatment response. Cyclotek’s R&D role is to help bridge the gap between promising radiopharmaceutical science and practical clinical access through manufacturing capability, quality systems, regulatory experience and clinical trial support.
R&D Capabilities
What Our R&D Programme Supports
Cyclotek’s R&D capability spans the translational pathway, from synthesis and method development through to GMP validation, clinical trial supply and commercialisation support.
Novel Tracer Synthesis & DevelopmentClinical Research
Radiochemistry development for new labelled compounds, amino acid analogues, receptor-targeted agents and selected biologics.
Method Transfer & GMP Translation
Taking research-stage synthesis protocols into validated production workflows, helping international and local tracers move towards clinical use in Australia and New Zealand.
Clinical Trial Manufacturing
Phase I-III investigational product manufacturing support, with quality systems and documentation to support HREC and TGA pathways where applicable.
Investigator-Sponsored Study Support
Supply and manufacturing support for clinician-led studies at hospitals and research institutions across Australia and New Zealand.
Tracer Validation & Qualification
Analytical validation and qualification of synthesis methods, QC protocols and production equipment before clinical use.
Commercialisation & Clinical Translation
Support for the pathway from clinical study to broader clinical access, including regulatory, reimbursement and commercial supply considerations where relevant.
Research Collaborations
Research Partnerships and Collaborations
Cyclotek works with academic institutions, hospital research units and biotechnology companies to bring novel tracers into clinical investigation and practical use across Australia and New Zealand. Cyclotek applies formal qualification and validation activities to confirm that equipment, processes and control systems perform as intended before routine production. Ongoing review and re-validation support continued performance, particularly after system changes, upgrades or regulatory requirements.