Bio isolators beat clean rooms

Two new bio isolators now available to researchers

First published: 17/02/2014

Updated at: 24/02/2014 at 9:24 am

New state of the art equipment for development of human cell and tissue therapies is now available at two Victorian research institutes.

BioSpherix Xvivo biological isolators are accessible to researchers seeking to manufacture cell and tissue therapies for preclinical and clinical studies.

St Vincent’s Institute (SVI) and Monash Institute for Medical Research (MIMR), with the support of the Victorian Consortium for Cell-based Therapies (VCCT), have used $2M of funding obtained from the

Federal Government’s Education Investment Fund to purchase, install and commission the two custom-built BioSpherix Xvivo biological isolators.

The SVI isolator is located at the O’Brien Institute in Fitzroy while the MIMR isolator is located at Cell Care in Heatherton. Both units have been installed in ISO Class 8 cleanrooms.
Contamination is the greatest risk to human cell and tissue processing, so manipulations need to be performed within a clean and controlled environment.

The new Isolators provide a complete barrier from environmental and operator-borne sources of contamination, from start to completion of processing, which is not readily achievable in a standard cleanroom setting. Each unit features:
• continuously recirculated filtered air
• laminar flow cabinets for the entry/removal of materials in/out of the isolator
• dedicated hot and cold processing chambers
• three independently controlled incubators
• a water-cooled centrifuge
• a microscope in a controlled environment
• temperature and gas controls (oxygen, nitrogen and carbon dioxide), adjustable to optimise processing or culturing requirements (e.g. hypoxic conditions for stem cells)
• particle monitoring and volatile organic compound sensors, for monitoring of air cleanliness

Nicole Bleasdale, VCCT Operations Manager, said “The isolators provide a cleaner environment with a lower risk of contamination than a conventional cleanroom set-up as they are fully contained. They also provide an operational advantage through reduced processing times and less time spent gowning-up.Operators can just wear hospital scrubs or laboratory coats instead of expensive cleanroom garments.

“The units provide a sterile environment to process human cells and tissue. For example, the SVI isolator is now being used for the isolation of pancreatic islet cells for administration to diabetes patients with hypoglycaemic unawareness.

“The Monash Isolator located at Cell Care will be used for a world first clinical trial involving the isolation of amnion epithelial cells for treatment of broncho-pulmonary dysplasia of the newborn. Amnion epithelial cells are extracted from the inner membrane of the placenta.

“Another use will be to process human bone marrow derived mesenchymal stromal cells for a phase I/II clinical trial in the treatment of Multiple Sclerosis.

“Both instruments have been fully commissioned and are available for use,” said Nicole.
SVI and MIMR are working closely with the Australian Red Cross Blood Service to develop and implement quality systems necessary to operate both facilities to Good Manufacturing Practice (GMP) guidelines.

For more information email Nicole:

You need to login or register to bookmark/favorite this content.