Name of Submitter:
Dr Martina Jones (QLD node) and Dr George Lovrecz (VIC node)- National Biologics Facility (UQ and
CSIRO)
Draft 2016 National Research Infrastructure Roadmap
Submission Template
Please provide your comments in this word document below, noting that the overall word count
should not exceed 1,000 words and any content exceeding this amount may not be counted as part
of your submission. If you would like your comments published, please ensure that your submission,
including all pictures, diagrams or tables adheres to online accessibility requirements as stated on
our Terms and Conditions page.
When your comments are complete, save this document in two of the accepted file types and upload
both documents to the Department submissions page in accordance with the instructions.
NBF response to the '2016 National Research Infrastructure Roadmap'
The National Biologics Facility (NBF) operates out of two nodes - one at the
Australian Institute for Bioengineering and Nanotechnology (AIBN) at the
University of Queensland, and one at the CSIRO Recombinant Protein
Production Facility in Melbourne. The two nodes were initially part of a larger
consortium of facilities under the NCRIS-funded Capability 5.5 Recombinant
Proteins group; based on the excellent performance outcomes of the AIBN and
CSIRO facilities, together with synergies based on complementary platform
technologies and skill-sets, these two facilities were merged into the National
Biologics Facility, and have received partial funding support for operational
staff through NCRIS via Therapeutic Innovation Australia.
NBF was pleased to see support in the Draft 2016 National Research
Infrastructure Roadmap for the focus areas of Therapeutic Development,
Characterisation and Complex Biology. The majority of NBF activities fall under
Therapeutic Development, including biologics and for target protein
production for small molecule antagonists, as well as Characterisation and
Complex Biology through the provision of a wide range of purified proteins or
cell culture samples for structural characterisation or genomics, proteomics
and metabolomics analyses.
As outlined in the Roadmap, there will be an increased demand for national
research infrastructure to provide screening and production of biotherapeutic
molecules, in part due to the establishment of the MRFF and BTF. Based on
the excellent track-record and the close vicinity to complementary capabilities
(Patheon Biologics, MATF, Australian Synchrotron etc.) the NBF is uniquely
placed to continue to provide the infrastructure and expertise required to
produce complex recombinant biologics/proteins to Australian researchers and
industry, provided the Facility continues to receive operational support.
To effectively meet the increased demand for Therapeutic Development, it will
be essential that the Program Governance principles outlined in the roadmap
are implemented for the focus area. Best-practice governance and
management will be required to ensure that the expectations of the public and
private stakeholders are met. Translation of therapeutic candidates through
to clinical trials requires years of research and development, so it is imperative
that service providers of infrastructure in this area have assurance of long-term
continuity .
1.4 Skills and Career Development:
NBF depends on the expertise of the core team of skilled staff to perform tasks
across the pipeline of capabilities of the Facility. This includes operations
management, technical staff and quality management.
The draft roadmap identifies that skilled technical and management staff are
essential to maintaining advanced research infrastructure capabilities, and
identifies that training of researchers is a key element in developing these
skills. The National Biologics Facility at AIBN provides infrastructure and
expertise to the recently awarded ARC Training Centre for Biopharmaceutical
Innovation, where five post-doctoral researchers and fourteen PhD students
will be trained in close association with industry partners CSL, Patheon
Biologics, GE Healthcare and Australian Red Cross Blood Service. The CSIRO
node of the NBF provides hands-on training for institutional and industry
scientists and has ISO9001 and cGMP (APVMA) accreditation to enable
industry benchmark production standards.
1.6 Access to research infrastructure
NBF provides access to researchers across the three broad categories: merit,
national interest and commercial. Meritorious access is given to academic or
research institutions across Australia at low cost, with labour costs subsidised
through NCRIS. A National Interest project is continuing in the production of
monoclonal antibody against the Hendra virus, both for Phase I clinical trial
and for compassionate use stockpiling. Commercial access is provided to small
biotech companies across Australia (>30 in the last three years). Several of
these companies have entered Phase I and/or planning Phase II clinical trials.
2.9 Therapeutic Development
NBF assists with both the discovery of potential drug candidates (through large
protein and chemical library screening) and production of candidate molecules
in mammalian and other cell culture formats. We can also assist researchers
to become ready for large-scale manufacturing through the generation of highproducing mammalian cell lines for their protein-of-interest. NBF has seen
increasing demand for access to antibody phage libraries for the isolation of
antibodies as potential immunotherapy.
Manufacture of high quality antibodies is highlighted in the included case study
for the manufacture of the m102.4 antibody against Hendra antibody. This
was manufactured under a quality management system, to ensure suitable
quality for human use during a Phase I clinical trial in healthy volunteers, and
for compassionate use in individuals exposed to the Hendra virus. NBF are
continually collaborating with Queensland Health to ensure stock levels of the
antibody are maintained. NBF scientists have played a key role in the
development of a lead therapeutic for eye disease (about to enter Phase II
trials), through a strategic alliance with Opthea, which involved the application
of a suite of skills in protein engineering, production and characterisation.
To continue to provide expertise and infrastructure in the area of Therapeutic
Development, NBF requires continued and additional support to maintain
management, technical and quality management staff, and to maintain the
state-of-the-art status of the facilities including equipment and ISO9001 and
cGMP (APVMA) accreditation.