TRI Clinical Manufacturing & Training Hub

TRI is home to a state-of-the-art, flexible and accessible clinical manufacturing and training hub. This is the only facility of its kind in Australia for the medical technology and pharmaceutical sector. Through this hub, TRI is accelerating the translation of new medicines and devices for early stage clinical trials. The services provided through this hub are open to researchers and organisations external to TRI.

PRODUCT MANUFACTURING

TRI provides the infrastructure and  regulatory compliance necessary for the small-scale manufacture of medicines and devices for human use. Our current Good Manufacturing Practice (cGMP) cleanroom facility is available for use by non-TRI researchers and commercial organisations. This facility is ideal for producing clean to sterile medical device, biotechnology, pharmaceutical and cell-based products for human clinical studies.

  • Five segregated, ISO14644/AS 1807.6/GMP compliant Class 5-7/Grade B/C cleanrooms, with dedicated isolator (with VHP sterilisation) for sterile processing and GMP autoclave. These are capable of servicing all levels of manufacture ranging from low-bioburden to sterile.
  • AP-IS 2 Pharmaceutical Isolator
  • Monitored, secured and alarmed GMP fridges and freezers
  • GMP autoclave
  • Sterile processing with continuous particle monitoring
  • Compliant, externally audited Pharmaceutical Quality System (PQS).  This means we are able to comply with industry regulations set by the Therapeutic Goods Administration (TGA), such as the PIC/s guidelines to GMP, and assure the quality of the system.
  • 24/7 critical systems monitoring, on-site security as well as swipe card restricted access to all rooms.

PROFESSIONAL TRAINING  

In collaboration with Vaxxas Pty Ltd, TRI offers professional training in cGMP manufacturing processes. Uniquely, our programs allow participants get hands-on experience using our cleanroom facilities. They are suitable for university-based researchers as well as people already working in the medtech and biopharma sector.

Bookings or more information:

T:   +61 3443 7848
E:   [email protected]