One of the key challenges in turning research and development into a commercial reality is to produce potentially valuable proteins in quantities large enough to support animal, pre-clinical and human Phase-I clinical trials.
To overcome this challenge CSIRO and Australian Institute of Bioengineering and Nanotechnology at the University of Queensland established the National Biologics Facility (NBF) to bridge the gap between research discoveries and the bioprocesses required to produce quality materials under ISO9001 and cGMP conditions.
CSIRO is also a member of the Victorian Antibody Initiative (VAI) to provide access to high quality antibodies and comprehensive gene-to-structure services.
Large scale protein production in a range of expression systems
The CSIRO node of NBF provide assistance with optimisation, scale-up, production and purification of recombinant proteins in large quantities, from hundreds of milligrams to kilograms.
We have a proven track record in fermentation and downstream processing of recombinant proteins, expressed in eukaryotic and prokaryotic hosts, such as mammalian, insect, yeast and bacterial cells.
Recent projects have included producing monoclonal antibodies, receptor signalling and cytokine proteins, antigens for establishing hybridoma cell lines and various bacterial and insect cell proteins for screening and diagnostic applications.
Our cell culture and fermentation equipment
Our facility is equipped with state-of-the-art cell culture and fermentation equipment including single-use bioreactors (both bag and stirred tank systems) and up 500L capacity traditional stirred tank reactors. Also, a wide range of systems are offered to scale-up anchorage dependent cells such as stem cells and primary cell lines.
Naturally matching downstream processing equipment to purify and fill-and-finish the proteins are also available.
Links to protein characterisation facilities
The facility is supported by the expert capabilities of various other molecular and cell biology groups to allow cell line development and protein chemistry for rapid purification and characterisation of proteins. We are also connected to the Bio21-C3 crystallisation laboratories and to the Australian Synchrotron to allow structural studies. Fragment based screening and protein-protein interaction studies are also available to identify suitable candidates for further pharmaceutical research.
Research and collaboration
The facility is working with academic and industry collaborators on the development of various biologics for human and animal use. Expertise is available to advise and assist clients on the areas of antibody discovery and engineering, mammalian cell line generation, production, purification and protein characterization. Both collaborative and fee-for-service agreements along with seamless process transfer to CMO are available.