Finding a path to market for laboratory successes can be a com
plex 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 $35 million the Australian Government is committing through the National Collaborative Research Infrastructure Strategy (NCRIS) will 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 biofuels.
Scaling up production of the potentially useful recombinant proteins will be done at three facilities to the level needed to support clinical trials. Researchers will then have subsidised access to licensed contract manufacturing organisations to produce their proteins in the quantities required.
NCRIS funding is expanding the national capacity to produce human cells under strict regulatory conditions. Funds will support the establishment and maintenance of Therapeutic Goods Administration (TGA) licenses for facilities in five States, together with subsidised access to these facilities for researchers to undertake expansion and processing of human cells and tissue.
Two pilot-scale facilities for development of novel biofuel production technologies are being developed – one to convert lignocellulosic biomass to ethanol and the other to convert microalgae to biodiesel. Related laboratory infrastructure at three universities is also being enhanced.
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
'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. These 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).
To expand the national capacity for the production human cells under strict regulatory conditions, support is being provided 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 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.
Funding has been committed to research infrastructure for the development of novel biofuel production technologies, including the construction of two pilot-scale facilities:
- 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 microalgae biomass culture for biodiesel production. This facility will be designed as a transportable laboratory that can be moved between pilot plant sites.
Three universities will provide support to researchers who have projects that are designed to produce improved technologies for the conversion of biomass to biofuels. Fermentation laboratories are being upgraded at the University of New South Wales, Macquarie University are expanding their enzymatic capabilities, and a research-scale high-pressure tube reactor is being built at the University of Sydney, building on their hydrothermal liquefaction skills.
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:
Dr Stewart Hay
Project Director
AusBiotech Limited
Level 1, 322 Glenferrie Road
MALVERN VIC 3144
Australia
Tel: +61 3 9828 1416
Mobile: +61 430 279 823
Email: shay@ausbiotech.org
For enquiries about the Human Cells for Transplant project, please contact:
Ms Jenny Morawska
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
Australia
Mobile: +61 438 295 056
Email: jennym@rissltd.com
For matters related to management of the NCRIS programme, please contact the NCRIS Team by email at ncris@dest.gov.au or by telephone on 02 6229 4223.
For further information on the Recombinant Proteins and Biofuels projects, please see the homepage of AusBiotech Limited at http://www.ausbiotech.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/