Our Facility

Our 13 cleanroom suites are purpose-designed for ex vivo manipulation of human cells. These include ISO-classified suites with integrated air handling systems, gowning zones, and flow controls to maintain GMP segregation and product integrity. Our capabilities span autologous and allogeneic workflows, with flexibility to adapt to a wide range of therapy modalities. The facility supports:

• Clinical and commercial GMP manufacturing
• In-house Quality Control and sterility testing
• Cryogenic storage and distribution
• Process development and scale-up transfer

Cell Therapies holds a comprehensive Therapeutic Goods Administration (TGA) manufacturing license that spans the entire value chain — from donor cell collection, through GMP manufacturing, quality control, cryopreservation, and final release. As Australia’s only facility with MHLW accreditation, we are uniquely positioned to supply regulated cell therapy products to Japan, one of the most advanced and complex regulatory environments for regenerative medicine.

Our proximity to the Asia-Pacific market and our embedded quality systems enable efficient and de-risked access to clinical and commercial pathways in Australia, New Zealand, Japan, South Korea, and Southeast Asia. We understand the logistical, regulatory, and clinical nuances of these jurisdictions, and we’ve developed dedicated systems for regulatory alignment, import/export, and cross-border documentation.

Our quality systems are built to withstand the scrutiny of global regulators. CTPL has undergone numerous successful inspections by the TGA, FDA, EMA, and PMDA, as well as by global biotech sponsors. We offer flexible, risk-based quality oversight that supports client programs from preclinical through post-market supply. Our QMS provides:

• Batch release and deviation management
• Vendor qualification and raw material oversight
• Product lifecycle and stability monitoring
• Clinical document generation (BMRs, CoAs, CTD Module 3 support)

Clients without in-house QA capabilities can leverage our team as an embedded quality partner, supporting audit readiness and regulatory alignment.

Co-located with one of the largest cancer research hospitals in the Southern Hemisphere, Peter MacCallum Cancer Centre, Cell Therapies provides the infrastructure and operational expertise required for rapid, safe, and traceable delivery of cell therapies to patients. We support the Centre of Excellence in Cellular Immunotherapy and have deep integration into clinical workflows, including direct-to-clinic product handoff, bedside thawing, and close coordination with hematology and oncology teams. Our facility is also used to train and credential healthcare professionals participating in advanced therapy delivery.