Finding a path to market for laboratory successes can be a complex process. A key challenge is producing potentially valuable compounds arising from biotechnology research (“biotechnology products”) in quantities large enough to support pre-commercial trials.
The Australian Government committed $35 million through the National Collaborative Research Infrastructure Strategy (NCRIS) to enhance Australia’s capacity to produce biotechnology products in pre-commercial quantities in three distinct areas:
recombinant proteins, for use as potential therapeutics;
human cells, for transplantation or clinical activity involving human subjects; and
NCRIS funding expands the national capacity to produce recombinant proteins, human cells and biofuels.
For the first time this NCRIS funding brings together a truly national infrastructure for this capability which will enable the acceleration of Australian biotechnology research and put us on a similar path to competing nations.
Until now, researchers have found it hard to find backing for the clinical-level testing of laboratory success stories. This has meant projects have wallowed as they wait for funding or access to drug development capability. NCRIS not only offers a financial subsidy to researchers so their projects can progress, but is also providing technical direction from start to finish to guide the development process. A flow has been established, from researchers to developers to manufacturers, which will nourish a greater understanding of each other’s needs with the result being a faster path to the clinic for potential protein targets.
Collaboration has been pivotal in this process and I believe this is just the beginning. NCRIS has motivated the research community and industry to collaborate, and in the longer term a more streamlined development process will emerge in biotechnology as a result.
Dr Michael Zachariou, Deputy Research Director, CSIRO Molecular and Health Technologies
Scaling up production of the recombinant proteins is done at three facilities to the level needed to support clinical trials. Researchers have subsidised access to licensed contract manufacturing organisations to produce their proteins in the quantities required.
'Feeder' facilities for protein expression and downstream processing are being established or enhanced at the Australian Institute of Bioengineering and Nanotechnology at the University of Queensland, the School of Biotechnology and Biomolecular Sciences at the University of New South Wales and a Victorian-based facility established jointly by Monash University’s ARC Special Centre for Green Chemistry and the CSIRO’s Division of Molecular and Health Technologies.
The recombinant proteins laboratory at the University of New South Wales has been upgraded with NCRIS funds and was launched in September 2009. The facility provides services in cell engineering, bioprocess development, protein production and protein purification to the Australian research community and industry.
Once ready, all three feeder nodes will undertake process development activities in preparation for manufacturing of proteins under GMP conditions.
To produce their proteins in the quantities required, researchers may also qualify for subsidised access to the licensed contract manufacturing organisations, Hospira Adelaide Pty Ltd and RadPharm Scientific (a Division of Global Medical Solutions Australia Pty Ltd).
Human Cells for Transplant
To expand the national capacity for the production of human cells under strict regulatory conditions, support is being provided through NCRIS for the establishment and maintenance of Therapeutic Good Administration (TGA) licenses for facilities in five States, together with subsidised access to these facilities for researchers to undertake the expansion and processing of human cells and tissue.
Facilities which are currently TGA-licensed and able to offer subsidised access under the NCRIS programme include the Queensland Institute of Medical Research, The Peter MacCallum Cancer Institute in Victoria, the SA Institute of Medical and Veterinary Science and the Royal Perth Hospital.
National Collaborative Research Infrastructure Strategy (NCRIS) funding has been committed to the establishment of research infrastructure for the development of novel biofuel production technologies. As part of the NCRIS project Recombinant Proteins and Biofuels project the following research infrastructure is being developed:
- a biomass biorefinery pilot plant in Queensland, located in Mackay and owned and operated by Queensland University of Technology, for the development and demonstration of the production of ethanol, lignin and other commodities from lignocellulosic biomass; and
- a photobioreactor facility in South Australia, located at the South Australian Research and Development Institute (SARDI), for pilot-scale development and demonstration of microalgal biomass culture for biodiesel production. This facility will be designed as a transportable laboratory that can be moved between pilot plant sites.
Three universities provide support to researchers who have projects that are designed to produce improved technologies for the conversion of biomass to biofuels. Fermentation laboratories have been upgraded at the University of New South Wales and Macquarie University is expanding their enzymatic capabilities. A research-scale, high-pressure tube reactor is being built at the University of Sydney.
A key principle of NCRIS is that the facilities funded by the programme should be accessible to researchers on the basis of merit at reasonable prices, wherever they are located in Australia.
For enquiries about the Recombinant Proteins and Biofuels projects, please contact:
Ms Nicole Bleasdale
Level 1, 322 Glenferrie Road
MALVERN VIC 3144
Tel: +61 3 9828 1416
For enquiries about the Human Cells for Transplant project, please contact:
Dr Stewart Hay
Chief Executive Officer
Research Infrastructure Support Services Limited
c/o The Australian Red Cross Blood Service
Level 6, 464 St Kilda Road
MELBOURNE VIC 3004
Tel: +61 3 9863 1715
Tel: +61 428 65 82 82
For matters related to management of the NCRIS program, please contact the NCRIS Team by email or by telephone on 02 6276 1998.
For further information on the Recombinant Proteins project, please see http://www.ncrisproteins.org/
For further information on the Biofuels project, please see http://www.ncrisbiofuels.org/
For further information on the Human Cells for Transplant project, please see the homepage of Research Infrastructure Support Services Limited at http://www.rissltd.com/