NCRIS Capability 5.5: Victorian Node Recombinant Protein Feeder Facility
Finding a path to market for discoveries arising from pure and applied research and development can be a complex and challenging process. A key challenge is producing potentially valuable compounds arising from R&D in quantities large enough to support pre-commercial investigations and trials. The Australian Government, the Victorian State Government, Monash University and CSIRO’s Division of Molecular and Health Technologies have invested in the National Collaborative Research Infrastructure Strategy (NCRIS) program that will enhance Australia’s capacity to produce recombinant proteins in pre-commercial quantities.
Scaling up production of potentially useful recombinant proteins under non-GMP conditions will be done at this Victorian node feeder facility up to the level needed to support pre-clinical trials. Researchers will then have subsidised access to licensed contract manufacturing organisations (CMOs) for production of recombinant proteins under TGA-licensed GMP conditions in the quantities required for Phase I-III clinical trials.
NCRIS has recognised the requirement for a national capability feeder facility for the non-GMP production of biotechnology products, The Victorian node feeder non-GMP capability is a collaborative initiative comprising two institutions, the Centre for Green Chemistry at Monash University and CSIRO’s Division of Molecular and Health Technologies (CMHT). The expert capabilities at the Victorian node feeder facility is based on their extensive experience in upstream, midstream and downstream processing of recombinant proteins expressed in both prokaryotic and eukaryotic hosts to provide regional and national process development needs at a world-leading standard.
The Victorian node feeder facility is housed in a newly refurbished, dedicated laboratory located in Monash University's Faculty of Science precinct at Clayton and a fully refurbished building located at the CMHT precinct immediately adjacent to Monash University.
The Value Chain for Recombinant Proteins
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