The Translational Research Institute in Brisbane sees the first clinical plant in Australia for cGMP education and production, dedicated to start-ups, researchers and students.
Available technologies also include the AP-IS aseptic isolator by Tema Sinergie.
AP-IS is an isolation system specifically designed for laboratories, pharmacies and pharmaceutical pilot productions. Its remarkable flexibility makes it an ideal equipment for all of those activities requiring the highest aseptic conditions, from dispensing through filling, up to sampling and transferring.
In Australia, the Translational Research Institute (TRI) in Brisbane, in partnership with Vaxxas, has been taking advantage of AP-IS to create a truly groundbreaking project meant to accelerate the translation of new medicines and devices for early stage clinical trials.
It’s all about a brand new clinical plant, a flexible open hub, the very first on the australian continent, conceived to make the most advanced technologies available to scientists and pharma start-ups, in the field of professional development and small-scale production of early stage clinical trials.
Available technologies count 5 cleanrooms, all of the required small-scale production gear, and the aseptic processing isolator system by Tema Sinergie. It’s a cGMP compliant class A/ISO 5 isolator, which can be used by start-ups and researchers both. As stressed by Michelle Richards, Director of Building Operations at TRI:
“It has the flexibility of being able to be used for anything from medical devices, to cellular therapies, gene therapies”
(quote from https://www.tri.edu.au/news/mtpconnect-podcast-tri-vaxxa)
Moreover, its full GMP compliance means it can offer a wide range of educational resources such as:
- Unidirectional airflow and HEPA filtration.
- Filters DOP testing.
- Monitoring of internal environmental parameters: air velocity, pressure, temperature and relative humidity.
- Particle (non-viable) and microbiological (viable) monitoring systems.
- Bio-decontamination processes thanks to the integrated VPHP generator and H2O2 sensors.
- Introduction/Extraction of material using Rapid Transfer Ports.
- Glove integrity testing using our Automatic Glove Leak Testing System (AGLTS).
- GMP compliant data acquisition, storing and reporting through Tema Sinergie’s DataWall – Data Management System.