The Victorian Consortium for Cell-based Therapies (VCCT) comprises over 20 public and private organisations with interests in cell and tissue-based therapies dedicated to facilitating and promoting translational research to improve patient outcomes. Administered by Monash University, through MIMR-PHI Institute of Medical Research, the Consortium has installed two custom-built BioSpherix Xvivo™ isolator systems within two Melbourne cleanroom facilities.
Development of these facilities was been funded by TIA under the Australian Government’s Translating Health Discovery program. The facilities have more recently received additional support in the form of soft infrastructure funding by TIA under the Australian Government’s National Collaborative Research Infrastructure Strategy (NCRIS 2013).
The Australian Red Cross Blood Service is assisting MIMR-PHI and SVI to implement the quality systems necessary to operate and maintain the facilities to cGMP guidelines, and providing support with the management and promotion of the activities of the VCCT.
Year of establishment: 2013
The VCCT Biological Isolator Facilities provide:
- A fully contained, controlled Good Manufacturing Practice (GMP) environment ideally suited for preclinical and early phase clinical manufacture of cell therapies
- A flexible, cost-effective alternative to conventional cleanroom facilities.
VCCT Biological Isolator Facility – St Vincent’s Institute
VCCT Biological Isolator Facility – Monash
The SVI BioSpherix isolator is located within an ISO Class 8 certified cleanroom at the O’Brien Institute on the St Vincent’s Hospital Campus (Fitzroy, Melbourne). The isolator has been certified to ISO Class 5, the required cleanliness classification for aseptic processing of human therapeutics.
Temporarily located at Cell Care (Moorabbin, Melbourne), in late 2015 the Monash BioSpherix isolator will be relocated to the Cell Therapy Platform (CTP) within the Monash Health Translational Precinct Translational Research Facility. A tissue bio-printer will be installed within the facility to provide tissue engineering capabilities.
Features of each BioSpherix Xvivo™ system:
Access and Pricing
- Laminar Flow Hood/s
- Heated processing chamber/s (ambient to 40C)
- Chilled processing chamber (4C to ambient)
- Three independently controlled incubators
- Fully adjustable temperature and gas controls (CO2, O2, N2)
- Particle monitoring and control
The isolators are available for processing of human cell and tissues intended for preclinical use and early-phase clinical applications. Access is conditional on the following requirements being met:
- Only human cells intended for preclinical studies or clinical application (ie no animal cells/tissue)
- Relevant Human Research Ethics Committee (HREC) approvals from the user's administering organisation
- Institutional Biosafety Committee (IBC) approval for projects involving GMOs or Risk Group 2 & 3 organisms
- Completion of facility induction and isolator training activities
- Compliance with site-specific Quality Management and OH&S policies and procedures.
Pricing and service provided are negotiated on a user-by-user (and project-by-project) basis with oversight from the VCCT Advisory Board and Management Committee. A simple User Agreement will be executed for each project/user.
Current projects utilising the facilities
- Islet cell transplantation for patients with unstable type 1 diabetes – St Vincent's Institute and St Vincent's Hospital
- Amnion epithelial cells as a treatment for bronchopulmonary dysplasia in very pre-term infants (Phase I clinical trial) – The Ritchie Centre, MIMR-PHI
Main contact: Nicole Bleasdale (VCCT Operations Manager)
Phone: +61 (0)439 923924
A PDF flyer exploring the VCCT isolator facilities can be downloaded here.