Cell Therapies

Overview

Cell Therapies is a GMP contract manufacturer specializing in complex cell-based therapies, with over two decades of experience spanning autologous and allogeneic modalities. The company supports programs from translational first-in-human clinical studies through late-phase trials and commercial supply.

Manufacturing & Process Development

• Cell Therapy Manufacturing: Licensed GMP manufacturing for autologous and allogeneic cell therapy products, including CAR-T cells, mesenchymal stromal cells (MSCs), tumor-infiltrating lymphocytes (TILs), and human pluripotent stem cells and derivatives.
• Technology Transfer: Phase-appropriate, risk-based framework across six gated stages (technical feasibility, knowledge capture, process implementation). Over 10 successful technology transfers in the last 4 years, including commercial CAR-T programs.
• Process Development: Dedicated PC2/BSL2 development laboratory with expertise in closed systems, automation, and rapid scale-up for early-stage clinical products; cost reduction and robustness optimization for late-stage and commercial programs.

Cold Chain & Logistics

• Validated cryopreservation using vapor-phase liquid nitrogen systems for apheresis collections, in-process intermediates, and final products.
• GMP-compliant labeling, storage, and chain-of-custody documentation.
• Established logistics partnerships supporting cryo-transport and direct-to-patient delivery across Australia, Asia-Pacific, and global clinical trial networks.

Quality Control & Analytics

• TGA-licensed flow cytometry (21 CFR Part 11 compliant).
• ddPCR and qPCR-based assays, ELISA, and cell-based potency assays.
• Rapid sterility (BacT/ALERT), endotoxin, and mycoplasma testing.
• Stability testing with cryopreservation protocols.
• Assay development, validation, and compliance infrastructure for early- and late-stage programs.

Regulatory & Consulting Services

• CMC road-mapping and regulatory gap assessments.
• FACT accreditation and GMP readiness support.
• Quality management consulting (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) with ongoing SME access.
• Quality as a Service (QaaS): fit-for-purpose QMS solutions for biotech companies, hospitals, and academic groups.

Regulatory Recognition

Quality systems have passed reviews by TGA, FDA, PMDA, and EMA. QMS implemented in hospitals to support stem cell collections, transplants, and cell and gene therapy delivery.