Sydney South West Area health Service

Cell and Molecular Therapies (CMT), Royal Prince Alfred Hospital are committed to the development of novel cell therapies and the subsequent improvement in survival and quality of life of patients who’s needs are currently unmet due to inadequate or absent capacity of such facilities in NSW (Section 1). The Apheresis and Bone Marrow Transplantation services of Cell and Molecular Therapies were the the first to be licenced in NSW by the TGA (Licence No. MI-06022007-L1-001711-11) in 2007 (Section 4).

Cells obtained from patients or normal donors have been used to cure cancers of the blood for decades.  These existing therapies require special attention at the points of cell collection, storage and release.  More recently, the opportunities to apply these cells in a broader range of diseases by altering them prior to their use has provoked intense interest.  Such experimental cell therapies are tightly regulated by the Therapeutic Goods Administration (TGA) which require that they be of a Good Manufacturing Practice (GMP) grade for use in clinical trials and therapies.  As a result only three publically owned cell therapy facilities are licensed in Australia and currently none of these are located in the state where most cancer patients reside, NSW. 

The CMT cell therapies production facility, the Cell & Molecular Therapy Laboratories (CMTL) design and fundraising have been finalised and are currently under construction with a completion forecasted for the end of 2009.  The CMTL has been designed to accommodate the needs of NSW clinical researchers, biotech and industry for the next 5 years (Section 3).  Furthermore, the CMTL has been designed with the necessary flexibility required to anticipated the changing requirements of the TGA. The CMTL will offer capacity for contract work to be undertaken by CMTL staff, external researcher staff training and protocol execution as well as available production space.

Research supported by the CMTL will be performance driven and deliver meaningful and highly significant outcomes.  The CMTL are also committed to promoting outstanding local research as well as supporting the high quality cancer research of its collaborators in NSW, nationally and overseas (Section 3).  It is anticipated that in the future advanced cell therapies may provide patients with shorter hospital stays, more out-patient treatment options and ultimately improved quality of life and survival.

CMTL GMP laboratory facilities:

The CMTL contains four cleanrooms with PC2 containment (GMP laboratory) designed to support clinical trials involving manipulated human cells (see Figure 4).  The CMTL has been designed in consultation with the Therapeutic Goods Administration (TGA), to provide a suitable environment for ex-vivo cell manipulation for human clinical trial consistent with the requirements for GMP and will be licenced by the TGA to carry out these processes.  The facility is dedicated to the selection, expansion, transduction (gene modification of cells), and/or other aspects of producing extensively manipulated human cell products for clinical trials. 

Cell and Molecular Therapies were the the first to be licenced in NSW by the TGA (Licence No. MI-06022007-L1-001711-11) in 2007.

Contact details:

  1.  John E.J. Rasko, BSc(Med), MBBS(Hons), PhD, FRCPA, FRACP  
    Director, Cell & Molecular Therapies, Sydney Cancer Centre, Royal Prince Alfred Hospital
    Head, Gene & Stem Cell Therapy Program, Centenary Institute of Cancer Medicine & Cell Biology
    Professor, Faculty of Medicine, University of Sydney
    Locked Bag No 6, Newtown NSW 2042, AUSTRALIA
    p: +61-2-9565 6156    
    F: +61-2-9565 6101
  2. Rosetta Martiniello-Wilks, PhD
    Production Manager, Cell and Molecular Therapy Laboratories, Sydney Cancer Centre, Royal Prince Alfred Hospital
    Conjoint Senior Lecturer, Central Clinical School (Medicine), University of Sydney
    Address: c/o Gene and Stem Cell Therapy Program
    Centenary Institute
    Locked Bag 6  Newtown NSW 2042 Australia
    P: +61-2-9565 6156     
    F: +61-2-9565 6101
    E: r.martiniello@centenary.usyd.edu.au
  3. Craig Wright
    Quality Manager, Cell and Molecular Therapies
    level 7 (West), E Block, Building 75
    Institute of Haematology, Royal Prince Alfred Hospital
    Missenden Rd Camperdown NSW 2050
    P: +61-2-9515-8176                  
    F: +61-2-9515 6331
    E:Craig.Wright@sswahs.nsw.gov.au