Cell & Tissue Therapies WA

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The Royal Perth Hospital, Ray and Bill Dobney Cell & Tissue Therapies WA (CTTWA) is a biotherapeutic manufacturing facility providing a diverse range of clinical products and services for the WA public health sector.

The core business of CTTWA is the manufacture and provision of clinical products and services for the WA Health sector.  This activity basis, along with a close interface with diverse medical specialities, has placed CTTWA in a strong position to embrace and assist in the translation of the emerging biotherapies. 

CTTWA has accommodated and assisted with several research projects involving biotherapeutic products for development, clinical trial evaluation at a local, national and international level.



Year of Establishment

 2006

Accreditations

  • GMP
  • CCTWA have five clean rooms of which four have ISO Class 7 certification and one large clean room with ISO Class 8
  • TGA product license for manufacture of MSC.

Access and Pricing

With five clean rooms within the manufacturing suite and access to research laboratories adjacent to the facility, CTTWA is able to manage manufacturing to best utilise the facility’s infrastructure and assist with research and development that can ultimately translate to the clinic.  CTTWA also has knowledge of and access to other WA public and hospital based infrastructure.  

Previous Clients

CTTWA has manufactured or is currently manufacturing cell therapies for the following eight clinical trials of which 6 have been supported by TIA (RISS Ltd) funding.  Two of the trials have been completed, both having positive outcomes and the other trials are underway or initiating.  The trials are:
  • MSC Therapy for Steroid Refractory GVHD, 2007-2009, Phase I, single site RPH, completed.
  • MSC Therapy for Steroid-Naïve Acute GVHD, 2012-2015, Phase II, currently single sited but expected that additional site will join study, recruiting.
  • Cell Therapy Recessive Dystrophic Epidermolysis Bullosa (RDEB, Fragile Skin) in Australia, 2008-2009, Phase I study, NSW, allogeneic skin fibroblasts culture expanded, completed.
  • MSC Therapy for Obliterative Bronchiolitis associated with Lung Transplant, 2008-ongoing, Phase I, double sited Australian, recruiting
  • MSC Therapy to Treat Biologic Refractory Crohn’s Disease, 2010-2013, Phase II study, multi-centred Australian, recruiting
  • Cranial Reconstruction using MSC with a Ceramic Carrier & Polymer Scaffold, 2012-2013, Phase II study, single-sited, Ethics approved, initiating.
  • MSC Therapy for Treating Chronic Obstructive Pulmonary Disease (COPD), 2012-2013, Phase I, single site, Ethics approved, initiating.
  • Potential of Mesenchymal Stromal Cells to Treat Antibody Mediated Renal Graft Rejection after Renal Transplantation from Living Related Donors, 2012-2013, Pilot study, single site, recruiting.
Another two clinical trials are under development.

KEY TECHNOLOGY

SERVICES

Manufacturing
Sterile tubing docker
Sepax system (BioSafe CH)
Cold Storage System
Flow cytometer
Cell Counter
Centrifuge
Bioreactors

Cell and tissue based product manufacturing

Facility Operations
Bar Coding System
Discrete building management system (BMS)
Reticulation of liquid nitrogen supply

 
Clinical trial services