Contract Manufacturing
For Pharma, Biotech & CRO Partners
Your Radiopharmaceutical CDMO partner in Australia and New Zealand
Cyclotek supports pharmaceutical and biotechnology companies, CROs, research sponsors and clinical partners with specialist radiopharmaceutical and radioactive medical device manufacturing capability. Our CDMO network provides access to GMP manufacturing infrastructure, phase appropriate quality systems, automation development, validation and clinical supply coordination, without partners needing to build and qualify their own local facility.
25+ Years GMP Experience
More than two decades of radiopharmaceutical manufacturing experience.
6
Licensed facilities across Australia and New Zealand.
Phase 0/I → Commercial
Scalable manufacturing capability supporting development from early-phase clinical trials through to commercial supply.
CDMO Capabilities
What our CDMO Programme Supports
Our CDMO capability spans the translational pathway, from synthesis and automated method development, through to GMP validation, clinical trial supply and commercialisation support.
Novel Tracer Synthesis & Automation Development
Radiolabelling method development for new small molecules, peptides, proteins 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.
Engagement Process
From Feasibility to First Batch
Cyclotek’s engagement process is structured to move efficiently from initial scoping to GMP production. Each project is supported by coordinated expertise across production, quality, regulatory and logistics functions.
Feasibility Assessment
We review the manufacturing protocols, release specifications, phase appropriate regulatory requirements and clinical trial scope to confirm fit with our facility capabilities and available synthesis platforms
Quotation & Agreements
A technology transfer and clinical trial supply quotation is provided, and the relevant commercial and regulatory agreements are negotiated before technology transfer begins.
Development, Technology Transfer and Validation
The manufacturing process is adapted or transferred, tested and validated to the required standard. SOPs, QC protocols, batch records and other documentation is developed as needed.
Clinical Trial Supply
Utilising our online ordering platform, product orders are received, manufactured and delivered to your clinical trial site.