The Centre for Blood Cell Therapies (CBCT) at the Peter MacCallum Cancer Centre
Peter Mac
As Australia’s foremost specialist cancer centre, Peter Mac provides quality treatment and support to patients and their families. Peter Mac is unique in Australia:
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It is the only hospital solely dedicated to cancer and it is one of an elite group of hospitals in the world that has its own integrated cancer research programs and laboratories. Its research program continually drives improvements in all aspects of treatment and clinical care. |
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It provides multidisciplinary holistic care – experts from all fields work together, providing the best care at all stages of illness and its oncologists sub-specialise in both common and rare types of cancer. |
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It has specialised equipment and technology enabling highly complex treatments to be administered safely. |
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Last year we offered 200,000 outpatient and 20,000 inpatient treatments. |
CBCT
This academic centre, affiliated with the University of Melbourne, administers two manufacturing licenses according to the code of GMP for Human Blood and Tissues:
Firstly- "Standard of care" autologous blood derived stem cells, referred to as HPC-A. These are harvested by apheresis at three locations- on the ward, in an on-site apheresis unit and at a nearby private hospital. Products are subjected to conventional processing in a non-cleanroom laboratory environment. Some testing is performed on-site (haematology counts, flow cytometry for CD34) whilst other assays are performed off-site (mandatory virus serology, NAT testing for HCV and HIV, microbiology). Products are stored either on-site at a large central store or if long term storage is required, product is shipped to Sydney for banking at Cryosite (also TGA licensed) indefinitely. CBCT was the first unit in Australia to seek licensing for banking, storage, testing, harvesting and manufacturing HPC-As and has held this license since 2001 and produces over 10% of Australia’s HPC-A.
Secondly- On behalf of Orthogen Australia we receive, process and culture autologous chondrocytes combined with a collagen matrix for implantation in patients with a focal defect in their articulating joints. Biopsies are collected and implanted in theatres off-site under our auspices. Similarly to HPC-A, we outsource some testing. Manufacturing takes place in one of our five AS1386 certified cleanrooms (comparable to ISO 14644 ISO7 rooms with ISO5 workzones). Treatments are manufactured by using collagenase to liberate chondrocytes from biopsies prior to plastic-adherent tissue culture and expansion. Once sufficient cells are available these are seeded into a collagen matrix which is shipped for implantation. This license was obtained in 2003.
The services at CBCT are underpinned by a Collaboration Agreement with the Australian Red Cross Blood Services who provide CBCT with a Quality Nominee. CBCT maintains strong academic interests in other forms of regenerative medicine and adoptive immunotherapy. In conjunction with its hospital owned commercial partner (Cell Therapies Pty Ltd) we also provide process development, trial development and contract manufacturing. These activities are not covered by our manufacturing licences. For instance we were pivotal in the process development and early phase studies for Mesoblast Ltd which used the locally generated data in non-union bone fractures and cardiac repair with mesenchymal cells for its own FDA IND approvals. 
We provide the resources for a pancreatic islet transplant program in this region. We also provide mammalian master cell bank manufacturing for immunotherapy in initial human studies and are currently developing genetically modified T cells for adoptive immunotherapy in haematology patients. A major interest is in radioactive labeling of cell therapy products for in-vivo human tracking using CT/PET and CT/SPECT using Indium, Copper, Fluorine and Yttrium chemistries.
