Our Services

Our experience in GMP manufacturing of complex and sophisticated cell-based therapies with global reach can support your program. We offer licensed GMP manufacturing for autologous and allogeneic cell therapy products throughout the development pipeline, from translational first-in-human clinical studies to late-phase trials and commercial supply.

Throughout our 20-years’ experience in the sector, Cell Therapies’ has significant experience in Technology Transfer across a broad range of cell and gene therapies. We’ve developed an efficient six‑gate Technology Transfer model focused on compression of timeframes and risk mitigation. We deliver quality and drive timelines without compromising comparability.

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

From day-zero patient apheresis to final filled vials and bags, Cell Therapies safeguards cell viability with industry‑leading cryo & cold‑chain protocols.

• Vapor‑Phase LN₂ Storage – validated ≤‑150 °C, with 24/7 telemetry
• Specialized Cell Types – iPSC derivatives, NK/TILs, macrophages
• Global & Regional Lane Management – Qualified shippers & GPS‑logged couriers (IATA PI 650/970)
• Excursion Response SOPs – <30‑minute alert → CAPA triage

Innovation meets manufacturability in our purpose‑built Process Development Laboratory. Our Process Development capabilities include expertise in closed systems, automation, and rapid process scale-up implementation for early-stage clinical products; while focusing on cost reduction, standardization, and process robustness for late-stage clinical and commercial products. We utilize a dedicated PC2/BSL2 development laboratory with access to emerging platform technologies and equipment to drive translation to the clinic.

Cell Therapies’ deep expertise and experience in manufacturing of complex cell-based products supports translation of pre-clinical research through the clinic to the market.

Assays that satisfy regulators and investors alike – Cell Therapies’ Quality Control (QC) laboratories combine gold-standard methods with novel analytics and digital traceability to de-risk release and stability profiles across autologous and allogeneic cell therapies. With deep regulatory experience across the clinical product lifecycle, we support early- and late-stage programs with robust assay development, validation, and compliance infrastructure.

Cell Therapies’ consulting arm is powered by scientific, regulatory, and operational leaders who’ve guided dozens of cell and gene therapy programs globally. From concept to IND to market, Cell Therapies supports your entire advanced therapy journey.

Cell Therapies’ quality systems are globally recognized and inspection-ready, having passed reviews by TGA, FDA, PMDA, and EMA. We offer flexible, fit-for-purpose Quality Management System (QMS) solutions for biotech companies, hospitals, and academic groups. Services include gap assessments, audit preparation, regulatory compliance support, validation support, and ongoing QA/QC consultation. For clients without in-house quality infrastructure, we act as an embedded partner, ensuring your program remains compliant, efficient, and always inspection-ready. We also provide interim quality leadership as a service.

Digitization is not optional – it’s a strategic differentiator. Cell Therapies’ digital transformation enables predictive insights, real-time transparency, and compliant automation across manufacturing and Quality Control (QC).