12 June 2019

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Press release

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TIA Announces $8M funding boost for the National Biologics Facility over the next 4 years

Therapeutic Innovation Australia (TIA) today announces $8M investment of funds in the three nodes of the National Biologics Facility (NBF) over the next 4 years. This funding is part of the Australian Government’s $2.1 Billion NCRIS program to support national research infrastructure.

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A biologic drug (biologics) is a product that is produced from living organisms or contain components of living organisms. Their use represents a major advance in medicine and are biologics are currently the fastest growing class of therapeutic compounds following the first FDA-approved biologic (Humulin®) in the early 1980s. The world’s best-selling drug, AbbVie’s Humira®, is a biologic administered to thousands of Australians to combat conditions such as Rheumatoid Arthritis, Crohn’s disease and Juvenile Idiopathic Arthritis.

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The global biologics market size is expected to be valued at US$480 billion in 20242 and the momentum continues to build, with over 130 FDA-approved proteins or peptides for clinical use with 1,500 biomolecules undergoing clinical trials[1],[2].

 

The key driving forces behind growing global usage of biologics are their proven safety and their ability to treat previously untreatable diseases particularly cancer and autoimmune disease. However, unlike traditional pharmaceuticals, biologics are large in size and are far more complex in structure. This means they are challenging and expensive to produce and store. Due to these difficulties, it is imperative that biologics being developed for clinical trials are developed and manufactured for clinical trials in state-of-the-art, specialized facilities that follow high-standard manufacturing guidelines. It is also imperative that these facilities are made available to the Australian research community. To support this access, TIA will invest ~$8M in the three NBF nodes across three states over the next four years:

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• Queensland Node (Australian Institute for Bioengineering and Nanotechnology, University of Queensland)

• New South Wales Node (GMP-lite facility, University of Technology Sydney)

• Victoria Node (Recombinant Protein Production Facility, CSIRO)

 

This investment in critical facility salaries will ensure a stable and expert workforce and is in addition to nearly $1M of investment in equipment in the Queensland and Victorian nodes already announced.

 

These investments will help to fill a gap identified in the 2016 National Infrastructure Roadmap, specifically the need for “National production facilities for making candidate biological molecules….of the appropriate pre-clinical and GMP clinical –grade quality” (p. 76, 2016 NCRIS National Research Infrastructure Roadmap).

 

NBF was established as an integrated platform of technologies and accessible expertise to support development of new biologic drugs, from discovery of biologics through early stage proof of concept, characterisation, cell line development, bioprocess development and advanced manufacturing capability.

 

The NBF has a track-record for progressing biologic drug candidates towards clinical trials, and includes the following translational outcomes:

• manufacture and provision of an antibody treatment for individuals exposed to the deadly Hendra virus (with Queensland Health)

• a protein drug treatment for Motor Neurone Disease (with the Queensland Brain Institute at UQ and NuNerve)

• an antibody for the targeted delivery of drug-loaded nanoparticles to tumours (for Sydney company EnGeneIc Pty Ltd)

• an antibody for tumour drug targeting (with Royal Adelaide Hospital, AusHealth Research)

• a protein in Phase II clinical trials for macular degeneration (with Opthea Pty Ltd) an antibody for the treatment of Graft vs Host Disease and potentially cancer immunotherapy (with Mater Medical Research Institute, ANZAC Institute and Dendrocyte Pty Ltd).

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Stuart Newman, TIA’s CEO, said:

 

“We are delighted to announce this new funding to the critical therapeutic area of Biologics. This class of therapeutics are already transforming healthcare and have the potential to lead to massive health and economic benefits to Australia. We are especially pleased to welcome the state-of-the-art GMP-lite facility at University of Technology Sydney to the NBF. These new investments in critical infrastructure are intended to support development of new therapeutics and realise this potential.”

 

Prof Stephen Mahler, Director of the NBFs Queensland Node and the ARC Training Centre for Biopharmaceutical Innovation, said:

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“The investment announced by TIA to support key national infrastructure in biologics R&D and advanced biomanufacturing capabilities ensures stakeholders in Australia’s growing biologics industry have access to critical expertise and infrastructure.  This investment will continue to enable the advancement of projects through the critical early stages of biologics development, facilitating translation to the clinic.

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We welcome the UTS-based node of the National Biologics Facility, adding a further dimension to NBF capability in training and advanced biomanufacturing.”

 

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About TIA

Therapeutic Innovation Australia (TIA) is a leading not-for-profit research infrastructure organisation that has received funding under the Australian Department of Education and Training’s National Collaborative Research Infrastructure Strategy (NCRIS) since 2008. TIA manages investment in hard and soft infrastructure to enable external access to key translational research capabilities, thereby enabling and accelerating translation of research discoveries towards clinical testing. To do this, TIA invests NCRIS funds in a consortium of capabilities that provide the translational benefits via state-of-the-art laboratory equipment and highly trained and experienced technical staff.

 

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