Facility designed to meet regulatory standards for GMP manufacturing of cellular therapies
Cell Therapies Pty Ltd (CTPL) has a GMP facility in Melbourne, Australia, that has manufacturing licences for clinical and commercial supply from Australia’s regulatory agency, the Therapeutic Goods Administration (TGA). This facility is located in the heart of the Melbourne Biomedical Precinct with access to hospitals, research institutes and universities to support the development and translation of cell-based therapies, along with increasing patient access for clinical trials. Capabilities include:
- Ten (10) clean rooms specifically designed for ex vivo cell therapy development and GMP manufacturing
- TGA Licence to Manufacture Therapeutic Goods for Clinical Trials – T-Cells, which includes cell collection, processing, storing, release for supply testing, flow cytometry, cell viability and immunobiological testing
- TGA Licence to Manufacture Therapeutic Goods for Commercial Supply – T-Cells, which includes cell collection, processing, storing, release for supply testing, flow cytometry, cell viability and immunobiological testing
- GMP-controlled clinical apheresis, cell cryopreservation, and storage facilities
- Critical infrastructure for the Peter Mac Centre of Excellence in Cellular Immunotherapy
Facility expansion coming 2022
Cell Therapies’ facility is in the process of expanding its footprint to include 1100m2 of additional cleanroom, testing and storage space. This facility expansion will be purpose-built for cell and gene therapy programs that require higher capacity, such as later stage clinical trial and commercially-available products. The manufacturing, quality and logistics systems that manage our current 10-cleanroom facility will be upgraded to include the facility expansion, and our TGA licences will be extended ensuring that all products manufactured meet the same rigorous regulatory standards.
The facility expansion will be fully commissioned in the first half of 2022.