The 2008 Strategic Roadmap for Australian research Infrastructure specified continuation of existing NCRIS-funded infrastructure for cell based manufacture of recombinant proteins as potential therapeutics, including the supply of therapeutic monoclonal antibodies in adequate quantities for evaluation, and of human cells or cellular based products for transplant.
Cell Based Therapies
Maintenance of cell therapy research has been identified as a key activity under the Strategic Roadmap for Research Infrastructure 2008 and the foundation has been established for a network of clinical therapeutic manufacturing facilities. Cell therapy approaches have flourished in recent years as a result of substantial infrastructure funding under the NCRIS program.
Growth in the cell therapy field has led to significant demands on infrastructure. Increasing activity has highlighted a number of constraints on the field including:
- A need for increased clean room capacity
- High costs associated with meeting regulatory requirements for manufacture
- High costs of regulatory compliance for clinical trials
- A requirement for scale up of activity
- Implementation of new technologies including new bioreactor technology
- A need for process development laboratories providing a link between basic research and cellular manufacturing facilities.
To address these infrastructure gaps and to sustain and capitalize on the previous federal government investment in the cell therapy area, funding will be directed at a small number of Centres.
Funding will be provided to:
Victorian Consortium for Cell-based Therapies (VCCT)
A public sector consortium consisting of Healthcare, Research Institutions and Commercial Organisations will facilitate research and translation of rapidly evolving cell therapies through clinical trials to the clinic. The consortium will scope and establish a public sector cell-based therapies facility in Victoria under the auspices of the Victorian Consortium for Cell-based Therapies (VCCT), in order to provide much needed cGMP facilities to VCCT members.
Cell and Tissue therapies WA (CTTWA)
A biotherapeutic manufacturing facility based at Royal Perth Hospital providing a diverse range of clinical products and services for the Western Australian public health sector. The funding will enable implementation of new technologies allowing efficiencies in manufacture and increased capacity.
Royal Prince Alfred Hospital (University of Sydney)
This facility is firmly established as one of Australia's leading cell therapy innovators and funding will be used to establish a Process Development and Clinical Trials Support laboratory as an essential component of a cellular therapies service. Such a facility will be the first of its kind in Australia.
Sydney Centre for Cell and Gene Therapy (at Westmead)
Cell therapy activity on the Westmead Campus currently provides support to three principal initiatives, the Pancreas Islet Transplant Group, the T cell adoptive immunotherapy programme and the Gene Therapy Research Unit. Funding will increase capacity for these activities and support GMP compliance.
SA Pathology (operating as IMVS)
A facility focused on developing immunotherapy for cancer. Super Science funding will enable enhanced genetic manipulation of cells and increased sophistication in cell processing and culture accelerating translational outcomes for this facility.
This project seeks to enhance recombinant protein infrastructure in order to maximise translational outcomes. Biopharmaceuticals, therapeutic proteins such as monoclonal antibodies produced by recombinant DNA technology, are now the most rapidly growing class of new therapeutic agents. The funding will be used to establish a national facility, accessible to Australian researchers, able to produce recombinant proteins from a range of expression systems and in sufficient quantities and purities to allow researchers to carry out pre-clinical evaluation and testing of the protein for its potential as a new therapeutic. The new facility will be based on the existing infrastructure for protein production in Brisbane, and in Melbourne. These two facilities have proven track records in bioprocess development and in the production of biopharmaceuticals for Australian researchers.
The new infrastructure will:
- Provide a form of protein expression platforms required by Australian researchers for the development of biopharmaceuticals.
- Develop monoclonal antibody discovery, expression, and conjugation platforms for use by the Australian research community.
- Allow the new facility to develop the technology required for the Biopharmaceutical Plant Of the Future (BPOF)
Collectively these new facilities will establish necessary biopharmaceutical protein expression ‘platforms’ enabling researchers with a target antibody or other proteins to move rapidly down the development pipeline.