Australian-based CDMO for Cell and Gene Therapy

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.

Our two decades of experience span autologous and allogeneic therapies across a wide range of cell types, including chimeric antigen receptor (CAR) T-cells, mesenchymal stromal cells, tumour-infiltrating lymphocytes (TILs), and human pluripotent stem cells and their derivatives.

Our technology transfer framework enables efficient onboarding of complex cell therapy programs into our GMP facility. We apply a phase-appropriate, risk-based approach across six gated stages from technical feasibility assessment, knowledge capture, to process implementation, ensuring operational continuity and reducing transition risk.

With over ten (10) successful technology transfers in the last 4 years (including commercial CAR-T programs), our team is adept at scaling diverse modalities under strict regulatory conditions.

Cell Therapies provides validated cryopreservation of clinical materials, including apheresis collections, in-process intermediates, and final products, using vapor-phase liquid nitrogen systems. Our GMP-compliant workflows include labeling, storage, and full-chain-of-custody documentation ensuring alignment with regulatory requirements for both clinical and commercial programs.

Our logistics partnerships and in-house support enable reliable, time-critical delivery across Australia, the Asia-Pacific region, and global clinical trial networks.

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.

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.

With over two decades of experience in GMP manufacturing of cell-based products, Cell Therapies is a trusted partner in transforming promising research into scalable, compliant, and commercially viable therapies.

Our dedicated Development Laboratory offers clients early access to established and emerging platforms, enabling the design of robust, phase-appropriate manufacturing processes grounded in real-world GMP requirements.

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.

Our in-house analytical and QC capabilities include:

• TGA-licensed flow cytometry (21 CFR Part 11 compliant)
• ddPCR and qPCR-based assays
• ELISA and cell-based potency assays
• Rapid sterility via BacT/ALERT
• Endotoxin and mycoplasma testing
• Stability testing with cryopreservation protocols

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’ consulting and advisory capability is a vital service that can assist clients to advance their cell and gene therapy program from pre-clinical development to treating clinical patients and future commercialisation.

We have expertise in navigating the challenges of manufacturing processes, regulatory requirements, quality standards, clinical needs, and logistics for the delivery of cell and gene therapies to patients in Australia and Asia Pacific region.

Services Offered

• CMC Road-mapping & Regulatory Gap Assessments
• FACT Accreditation & GMP Readiness Support
• Quality Management Consulting (quality by design (QbD), risk assessments)
• Facility Build-vs-Buy Feasibility For Early-stage Innovators
• Asia-Pacific Clinical Feasibility Assessment and Country Selection
• Regulatory Agency Meeting Support and Submission Strategy
• Quality Consultation as a Service (QCaaS) (ongoing subject matter expert (SME) access

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.

Embedded within the Peter MacCallum Cancer Centre, one of the largest cancer research hospitals in the Southern Hemisphere, we are uniquely positioned to support clinical trial supply in Australia and across APAC. Our integration with hospital networks and clinicians ensures that advanced therapies are delivered safely, efficiently, and in compliance with regulatory requirements.

Cell Therapies provides GMP manufacturing, cryopreservation, and validated logistics to enable smooth trial execution. With regulatory alignment through the TGA and recognition by global agencies, we help sponsors accelerate trial initiation and patient access while minimizing operational risk.