Monash Bioproducts Production Facility

Monash University, in collaboration with the CSIRO Material Science and Engineering Division, provides unique combination of platform technologies and capabilities in a powerful combination for the development of more efficient, sustainable and cost-effective protein production and purification.

Contact

Dr. Simon Harris

(613) 9905 9483


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Post author: Simon Harris. Last update: 30/10/2015 at 10:23 am by Simon Harris.

Overview

NCRIS has recognised the requirement for a national capability feeder facility for the non-GMP production of biotechnology products that will facilitate the path to market for new biologics-based therapeutics by hastening the transition of innovative research into the clinic. Monash University in collaboration with CSIRO’s Division of Molecular and Health Technologies hosts the Victorian Node of the NCRIS Recombinant Proteins Feeder Facility. This facility functions to provide national and international standard infrastructure and supporting expertise across the collaborating partner organisations and to provide a national capability that can be accessed by other research and development organisations and industry partners. Additionally, the infrastructure can be utilised for core university research and development activities. The expert capabilities at the Monash Bioproducts Production 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.
An objective of this facility is to produce potentially valuable recombinant protein compounds as potential biologics arising from R&D in quantities large enough to support pre-commercial investigations and clinical trials. Scaling up production of potentially useful recombinant proteins under non-GMP conditions will be done at this 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.

Details

Benefits

Know how:Protein Purification and Production Services:

  • Upstream and midstream processing is performed in a newly refurbished facility at CSIRO’s Division of Molecular and Health Technologies at Clayton, encompassing:
  • Fermentation
  • Cell culture
  • Harvesting
  • Filtration and concentration

The Monash site of the Victorian Node Recombinant Protein Feeder Facility is housed in a fully refurbished, dedicated site at the Clayton campus. This facility is equipped with state-of-the art equipment for automated high throughput ligand and resin screening for process development, optimisation, validation and intensification for efficient protein purification schemes and complementary analytical/characterisation methods that result in:

  • Translational scale-up of processes
  • Final product in high purity
  • Maximum yield
  • Process economy

The Monash site is also fully equipped with a suite of protein purification equipment for downstream bioprocessing activities for production of recombinant proteins at all process production scales from laboratory-scale through to pilot- and process-scale to meet the needs of a broad range of academic and commercial clients.

  • Non-GMP Purification of Recombinant Proteins (Downstream Processing):
    • Synthesis of novel ligands for affinity chromatography
    • High throughput ligand and resin screening
    • Method development, intensification and optimisation
    • Laboratory scale protein purification (10mg)
    • Pilot scale protein purification (0.1-10 g)
    • Process-scale protein purification (100 g+ quantities)
    • Ultrafiltration/Diafiltration
    • Protein characterisation and proteomics analysis
    • QC/QA

    Expertise:Availability of technical support:

    • Technical support is available

    Note that this material was imported form the Victorian Bioportal and content requires updating.

Access
People

Dr. Simon Harris

Dr. Simon Harris

Facility Manager at Monash University, Clayton Campus.

P: (613) 9905 9483 | Email |

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Location

Categories


Type: Core facility in a research organisation
Discipline areas: Biological Science
Precinct: South east
Affiliations: CSIRO, Monash University

Biological Science categories: Proteins and peptides