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
NCRIS funding along with support from the Queensland Government and The University of Queensland has enabled the AIBN to further strengthen their expertise and capabilities in mammalian cell technology. 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.
• Access to stable and transient protein expression systems.
• Fluorescence Activated Cell Sorter (FACS) and robotics for rapid isolation of high-producing clones.
• A variety of bioreactors up to 100L scale, including stirred-tank and disposable systems.
• Dedicated processing suites for product 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, from the generation of well-characterised cell lines to the design of bioprocesses suitable for large-scale 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 Capability 5.5 Biotechnology Products. The Victorian Node has capabilities in the optimisation, scale-up production and purification of recombinant proteins expressed in both prokaryotic and eukaryotic hosts under GLP conditions for use in pre-clinical research.
The upstream facility is located at CSIRO’s Molecular and Health Technologies laboratory immediately adjacent to Monash University at Clayton, while the downstream facility is housed in a newly refurbished, dedicated laboratory located in Monash University’s Faculty of Science precinct.
The following diagram illustrates the division of capabilities at the Victorian Node:
The capabilities of the Victorian Node include:
• Cell line development
• E.coli, baculovirus, yeast and mammalian expression systems
• A variety of bioreactors up to 500L scale, including stirred tank, perfusion and disposable systems.
• Product recovery systems, including tangential cross-flow and continuous homogenisation.
• Integrated chromatography systems capable of purification of milligrams to grams of protein.
• A robotic laboratory workstation for high throughput resin screening, method development, process optimisation, validation and transfer to scale-up purification capabilities.
• Protein analysis and characterisation equipment including high performance liquid chromatography (HPLC), preparative and analytical fast lipoprotein chromatography (FLPC) and mass spectrometry (MS).
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.
NCRIS funding has enhanced the capabilities of the facility to further enable provision of a range of services, including:
• 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. NCRIS funding has enabled Hospira to upgrade their facilities and quality system to achieve ICH Q7 “Guide for Active Pharmaceutical Ingredients” compliance.
• Cell line development and GMP cell banking.
• Proprietary expression systems using qualified host strain for production of human therapeutics.
• Process design and process development in accordance with ICH Q8 "Pharmaceutical Development" - Quality by design
• PEGylation technology
• TGA licensed, purpose built 1000m2 GMP production facility (commissioned in 2003). Manufacture in accordance with ICH Q7 "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients"
• Fermentation at working volumes of 100L and 500L
• Downstream processing and purification suites, housing homogenisers, GMP bioprocess system for chromatography (ion exchange, hydrophobic, gel filtration), tangential flow filtration etc
• Comprehensive suite of analytical equipment for physiochemical analysis and impurity testing (RP-HPLC, FPLC, MS, peptide mapping, N-terminal sequence, IEF, SDS-PAGE, vector integrity, amino acid analysis, endotoxin, bioburden, host cell protein, residual DNA, stability indicating assays, release assays).
• Dedicated teams for manufacturing / QA / QC / Validation / Regulatory Affairs
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.
NCRIS funds have been utilised to upgrade its facilities and expand its aseptic fill capacity to meet the requirements for phase I/II clinical research.
The capabilities Radpharm is able to offer through NCRIS include:
• Formulation development
• Automated aseptic filling and stoppering of the following vial sizes - 2mL, 5mL, 10mL, 20mL and 50mL. Minimum batch size is 500 vials.
• Lyophilisation (freeze-drying)
• Gamma, steam and dry heat sterilisation
• Packaging
• Quality analysis (limited) and release
• Stability studies
• Regulatory consultancy for CTD submission
For further information on the capabilities offered at this facility:
Ross Hanna or Majella Clifton
Email: Ross.Hanna@radpharm.com.au or majella.clifton@radpharm.com.au
Telephone: +61 2 6251 6533
Facsimile: +61 2 6253 3325
