Australian-based CDMO for Cell and Gene Therapy

We offer licensed GMP manufacturing for a wide range of autologous and allogeneic cell therapies, including CAR-T cells, mesenchymal stromal cells (MSCs), and iPSC-derived products. Our expertise spans the product development pipeline through first-in-human clinical research studies, early phase and late phase clinical trials, and commercial supply for patients across Australia and the Asia Pacific region. Delivered under one roof with embedded quality, regulatory oversight, and clinical integration.

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.

Cell Therapies’ deep scientific and technical expertise with complex cell-based products, when applied to your development program, will provide benefits to performance, cost, timeline, and compliance.

We support translational and late-phase clients with robust, scalable, and cost-efficient process development. Our dedicated Process Development Laboratory is equipped for closed-system development, automation evaluation, and rapid scale-up from preclinical proof-of-concept to commercial manufacture.

Cell Therapies’ Quality Control (QC) and analytical laboratories are licensed by the TGA and equipped for in-process, release, and stability testing. Capabilities include ddPCR, qPCR, ELISA, flow cytometry, cell-based potency assays, sterility (BacT/ALERT), endotoxin, and mycoplasma testing.

We specialize in assay development, method qualification, and regulatory-compliant validation, offering clients integrated support across the product lifecycle.

We provide strategic guidance across the cell and gene therapy value chain, from preclinical planning to global commercialization. Our team brings deep quality, CMC, regulatory, and operational expertise to help you de-risk development and accelerate timelines.

Services include quality consulting, technical feasibility assessment, regulatory road mapping, GMP readiness, facility assessment, and custom feasibility studies. Whether you are preparing for first-in-human trials or scaling globally, our consulting services ensure alignment with evolving regulatory standards while preserving program agility.

Our process development services bridge discovery and GMP manufacturing, enabling efficient translation from concept to commercialization. With expertise in closed systems, automation, and advanced analytics, we design scalable, reproducible, and cost-effective processes tailored to your product.

From target product profile workshops and rapid prototyping through validation and GMP transfer, Cell Therapies de-risks scale-up while maintaining regulatory alignment. Our purpose-built labs and expert teams ensure your therapy is both clinically impactful and commercially viable.

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.