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

 

These capabilities and facilities are available on a fee-for-service basis in conjunction with our services.  Please contact us today to get started.