Process Development 'Feeder' Facilities
Protein expression, purification and characterisation capabilities in Australia have been enhanced by the establishment of 'feeder' process development nodes in Queensland, New South Wales and Victoria. Eligible researchers are able to access the infrastructure and technical support made available under NCRIS to progress their therapeutic candidate along the drug development pipeline.
Australian Institute of Bioengineering and Nanotechnology (AIBN), Brisbane
The AIBN’s Biologics Facility is able to provide a comprehensive range of services; from cell line development through to downstream process development and protein characterisation.
The facility offers the following capabilities:
- Antibody engineering;
- Mammalian and baculovirus expression systems;
- FACS and robotics for rapid isolation of high-producing clones;
- Fermentation systems to 100L scale;
- Recovery and purification, with chromatography systems capable of producing milligrams to grams of protein;
- Characterisation of proteins, including testing for aggregates, product variants and stability;
- Expertise in pre-clinical biopharmaceutical development and production.
For further information on the capabilities available at the AIBN, contact:
Dr David Chin
Email: david.chin@uq.edu.au
Telephone: +61 7 3346 4269
Fascimile: +61 7 3346 3973
CSIRO and Monash University, Melbourne
CSIRO, in conjunction with the Centre of Green Technology at Monash University, make up the Victorian Node of NCRIS Biotechnology Products. The upstream processing facility is located at the CSIRO's Clayton laboratories immediately adjacent to Monash University, while the downstream facility is housed in a newly refurbished, dedicated laboratory located in Monash University’s Faculty of Science precinct.
The capabilities of the Victorian Node include:
- Cell line development and optimisation;
- Mammalian, baculovirus and bacterial expression systems (transient and stable protein expression);
- Conventional and single use bioreactor systems;
- Microbial capacity to 500L scale;
- Tissue culture capacity to 150L scale;
- Process optimisation and transfer to CMOs;
- Integrated chromatography systems for purification of milligrams to grams of proteins;
- High throughput screening and method development processes;
- Protein characterisation and analysis.
For further information on the capabilities offered by CSIRO, contact:
Dr George Lovrecz
Email: george.lovrecz@csiro.au
Telephone: +61 3 9662 7348
Fascimile: +61 3 9662 7101
For further information on the capabilities offered by Monash University, contact:
Dr Simon Harris
Email: Simon.Harris@sci.monash.edu.au
Telephone: +61 3 9905 9483
Fascimile: +61 3 9905 8501
The University of New South Wales, Sydney
The University of NSW Recombinant Products Facility is centred on a dedicated bioprocessing laboratory complex established over 15 years ago. The facility has provided cell line development, bioprocess development and protein production services to the research community and industry during this period.
Capabilities include: 
- Yeast, E.coli and mammalian expression systems;
- Cell line and hybridoma development;
- Cell line characterisation;
- Bioreactors for microbial fermentation (E.coli and yeast) to 25L scale;
- Stirred tank bioreactor and disposable systems for mammalian cell culture to 10L scale;
- Chromatography systems capable of protein purification at small scale;
- Protein characterisation and analysis;
- HPLC, MS and other proteomic services via the Bioanalytical Mass Spectrometry Facility also located at the UNSW (http://www.bmsf.unsw.edu.au/).
For further information on the capabilities offered at this facility, contact:
Dr Chris Marquis
Email: c.marquis@unsw.edu.au
Telephone: +61 2 9385 3898
Fascimile: +61 2 9313 6710
GMP Production Facilities
Facility upgrades of two GMP manufacturing facilities has increased capacity available for eligible researchers requiring production and 'fill and finish' of clinical grade material.
Hospira (protEcol Services), Adelaide
Hospira Adelaide is a TGA licensed facility that specialises in cGMP contract manufacture of therapeutic peptide and proteins using E.coli expression systems.
Hospira Adelaide's NCRIS capabilities include:
- Cell line development and GMP cell banking;
- Process design and process development;
- Analytical characterisation;
- Formulation development;
- Stability testing;
- Regulatory support;
- cGMP manufacturing (10L, 100L and 500L).
For further information on the capabilities offered at this facility, contact:
Dr Anne Collins
Email: protEcolservices@hospira.com
Telephone: +61 8 8234 2660
Fascimile: +61 8 8234 6268
Radpharm Scientific, Canberra
Radpharm Scientific, a Division of Global Medical Solutions Australia Pty Ltd, is a TGA licensed facility with strong capabilities in aseptic fill and finish.
Radpharm Scientific's NCRIS capabilities include:
- Aseptic process validation;
- GMP aseptic fill and finish;
- Filling of syringes, vials and specialised components;
- Formulation development;
- Vial washing and depyrogenation;
- Automated vial filling and stoppering;
- Lyophilisation (freeze-drying);
- Gamma and steam sterilisation;
- Packaging;
- Contract analytical testing;
- Contract stability program management;
- Regulatory consultancy for CTD submission;
- GMP consulting.
For further information on the capabilities offered at this facility contact:
Charles Ross or Majella Clifton
Email: Charles.Ross@radpharm.com.au or majella.clifton@radpharm.com.au
Telephone: +61 2 6251 6533
Facsimile: +61 2 6253 3325
