The challenge
Creating commercial products
One of the key challenges in turning biological research into commercial products is the production of potentially valuable proteins in quantities large enough to support animal, pre-clinical and human Phase-1 clinical trials.
Biopharmaceuticals encompass a range of entities including recombinant protein-based drugs, vaccines, cells and tissues. The global market for biologics (protein-based drugs) is predicted to be worth nearly US$480 billion by 2024. In addition, recombinant proteins are a significant global economic driver of both vaccine and biomarker development.
The rapid acceptance and growth of biologics means that there is now significant public and private sector research to develop novel biologics for better treatment of disease. Most biologics are large complex proteins that need to be produced by recombinant mammalian cell lines, requiring specialist infrastructure and expertise to develop the cell lines and produce the small quantities of biologics needed for laboratory and pre-clinical testing.
Our response
New national facility
To address this challenge, CSIRO and the Australian Institute for Bioengineering and Nanotechnology at the University of Queensland established a National Biologics Facility (NBF). The Facility received its original funding through NCRIS from 2006 and subsequently from the Education Investment Fund and Super Science Initiative. Subsequently, the Victorian Government contributed $1 million to establish the CSIRO-based pilot-scale Protein Production Facility, which is the Victorian Node of the National Biologics Facility.
The Protein Production Facility provides key infrastructure (both hard and soft) to support therapeutic discovery, from screening of antibody libraries and production of recombinant proteins as small-molecule drug targets, through to novel, engineered biologics, vaccine antigens and diagnostic reagents.
Access to the Protein Production Facility is available to both academic and industrial users through service or collaborative agreements. Services are also provided to researchers from Australian public sector research institutes and universities, small R&D based biotechnology companies and commercial companies
The results
Assisting Australian researchers
Since 2011, the CSIRO Protein Production Facility has assisted more than 70 clients and completed more than 300 major projects. Approximately 70 per cent of the Protein Production Facility's capacity is utilised by external academic and biotechnology industry clients. The facility plays a critical role in assisting Australian researchers to obtain sufficient material to undertake clinical trials. In doing so, the Facility is playing a critical role in catalysing innovation in the Australian biomedical sector.
Based on conservative valuations suggest that the total quantifiable benefits attributable to the CSIRO Protein Production Facility would be at least $36.65 million per annum. This is 8.5 times the average annual cost of the Facility.