Clinical Trial Support

We are integrated into Australia’s well-developed healthcare system and have extensive experience delivering complex cell-based therapies to clinical trial sites.

Cell Therapies is a trusted GMP manufacturer of cell-based therapies. The therapies we manufacture meet global regulatory and international organization for standardization (ISO) standards benchmarked by the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S).

Cell Therapies has experience supporting clinical programs in Australia with the Therapeutic Goods Administration (TGA). The TGA offers two tracks for clinical trial establishment in Australia including the expedited Clinical Trial Notification (CTN) scheme, which is the fastest pathway to clinical trial approval in the world.  The TGA has mutual recognition agreements with Europe, United Kingdom, Canada, Singapore and New Zealand, and has cooperative agreements with the United States Food and Drug Administration (US FDA) and the European Directorate for the Quality of Medicines (EDQM).

We have the capacity to maintain thousands of patient/donor collections and final products on-site in GMP conditions with our validated vapour-phase liquid nitrogen storage tanks.  Our partnerships with multiple global transport leaders and our in-house logistics capabilities enable Cell Therapies to deliver cell-based products to treat patients in Australia and across the Asia Pacific region.

At Cell Therapies, we understand that the delivery of innovative cell-based therapies to patients requires deep clinical integration. We have built strong relationships with clinicians around Australia and globally, and these are key to efficient clinical trial establishment across multiple sites.

Cell Therapies have established multicontinental manufacturing networks to support trials concurrently registered in Australia, Asia Pacific, Europe, and North America.