Contract Manufacturing

Cell Therapies has supported clinical trials for over 20 years, including Australia’s first CAR-T clinical trial. Our manufacturing systems are designed to adapt phase-appropriate controls, ensuring regulatory compliance while maintaining production flexibility. With Australia’s world-class clinical infrastructure, top-tier CROs, and access to the R&D Tax Incentive, we help clients open clinical trials in Australia quickly and efficiently, while generating data supportive of global filings.

Our 13-suite Melbourne facility includes three high-throughput commercial-grade suites capable of delivering thousands of cell therapy doses annually. CTPL has supported commercial product launches and is licensed by the TGA and aligned with FDA and EMA GMP requirements. Our Pharma 4.0 digital infrastructure ensures traceability, lowers COGS, and accelerates turnaround times. Robust ESG frameworks and ISO accreditations position Cell Therapies as a low-risk, high-compliance partner for APAC commercial supply.

Our phase-appropriate PD services are built to de-risk CMC and scale-up challenges. We specialise in flexible early-stage platforms and late-stage cost optimisation. Using closed systems (e.g., Cocoon, CliniMACS Prodigy) and PAT tools (e.g., in-line flow cytometry), we optimise processes that are scalable, reproducible, and audit-ready.

We manage tech transfers through a gated 6-step process, ensuring rigorous knowledge capture, process harmonisation, and quality alignment. Our TT process is supported by trained project teams, detailed risk assessments, and real-time documentation tools, ensuring smooth and timely operationalisation for both clinical and commercial programs.

Our facility houses validated vapour-phase liquid nitrogen cryostorage and integrated digital inventory systems. With established logistics partners, we provide qualified cryo-transport to hospitals and clinical sites across Australia, Asia, and globally. We also support direct-to-patient delivery models for time-sensitive autologous therapies.

Through our Asia Pacific Alliance Model (APAM), Cell Therapies provides clients with a single contract and a harmonised quality standard across Australia, New Zealand, Singapore, Korea, and Japan. Our hybrid model blends centralised GMP manufacturing in Melbourne with distributed clinical execution, regulatory alignment, and QC coordination across the region.

Digitization is not optional—it’s a strategic differentiator. CTPL’s digital transformation enables predictive insights, real-time transparency, and compliant automation across manufacturing and QC.