Therapeutic Product Facility

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The Therapeutic Products Facility (TPF) was constructed in SA Pathology laboratories on the campus of the Royal Adelaide Hospital. The Therapeutic Products Facility aims to provide a facility where cellular based therapies can be manufactured to the highest standards of purity, integrity, safety and strength. Within the TPF there is a strong focus on product quality and safety at all times. The TPF provides physical and intellectual support clients in the manufacture of cellular based therapies of the highest quality by providing workspace, training, infrastructure, materials and a quality system that complies with the applicable Code of Good Manufacturing Practice.  

Accreditation:

  • cGMP
  • TGA license for manufacture of
    • Haemopoietic progenitor cells (HPC) – blood and marrow derived, autologous and allogeneic
    • Autologous cultured chondrocytes
    • Autologous fibrin glue
    • Autologous cultured keratinocytes  

Year of Establishment: 2000  

Previous Clients:

  • CARPETS: A Phase I Open Label Study of the Safety and Immune effects of an Escalating Dose of Autologous GD2 Chimeric Antigen Receptor-Expressing Peripheral Blood T Cells in Patients with Metastatic BRAF-Mutant and GD2-Positive Melanoma
  • CML Vaccination and Interferon to enable withdrawal of imatinib treatment
  • Establishment of ex-vivo natural killer cell (NKC) immunotherapy protocols
 Key Technology Services 
Three positive pressure cleanrooms Chimerism analysis
MaxCyte® GT™ Transfection System (installation completed in end of 2013) Autologous tear drops
Electronic equipment monitoring Platelet gel
Volumetric air sampling equipment AML prognostic testing
Cell processing equipment  (installation completed in end of 2013) Mesenchymal stromal cells
Flow cytometer Archival malignant cell bank