Publish Date: 
Friday, August 2, 2019 - 09:00

MTPConnect Podcast: Learn about the upcoming small-scale manufacturing & training facility at TRI

In the latest episode of the MTPConnect Podcast Series, TRI’s Michelle Richards and Charles Ross from Vaxxas talk about the new TRI Clinical Manufacturing and Training Hub to open later in 2019. 

Supported by the MTPConnect Growth Centre Initiative, the project is a collaboration between TRI and Vaxxas, a technology startup based at TRI specialising in next generation vaccine technology.

The first of its kind in Australia, this hub will assist start-ups and researchers to translate new therapeutics, devices and diagnostics from bench to bedside, by enabling small-scale manufacture of early stage clinical trial products and providing hands-on training to upskill staff and students in pharmaceutical manufacturing.

The facility complies with Good Manufacturing Practice (GMP), with five clean rooms and essential equipment to enable small-scale clinical manufacturing including a state-of-the-art isolator to enable aseptic processing, GMP autoclave and instruments including particle counters, active air samplers and integrity testers. This will enable production of injectables, medical devices, diagnostics, nanoparticle systems, combination drug and device products for use in early stage clinical trials. 

What we have now is this super flexible, super accessible facility... where people can come in and manufacture their early stage clinical trial product. Staff will be trained up at the facility....then these people can be a pool of staff for commercial entities to use to manufacture their product”, explains Charles Ross, Head of Clinical Operations and Supply at Vaxxas. 

There is no other facility in Australia which has this type of cleanrooms, and this flexibility, and also has cleanrooms that are this accessible," adds Mr Ross.
 
Located at the TRI, on the PA Hospital campus, these facilities are conveniently located adjacent to to the Clinical Research Facility for early stage human trials. 
 
Michelle Richards, Director of Building Operations at TRI, explains how the hub will benefit the research ecosystem in Australia. "This facility fits in between an academic and a contract manufacturing facility. It has got flexibility to enable research and development in a GMP facility as well as GMP production of those products."
 
"They can actually go through the stages of development, through to licensing their product, in the same facility. Vaxxas might be in one room doing products for their Phase I and II clinical trials, and in the next room we could have students learning, hands-on, how to use an isolator for vaccine production. It has the flexibility of being able to be used for anything from medical devices, to cellular therapies, gene therapies," adds Ms Richards.
 

Listen to the 'MTP skills and manufacturing capabilities with TRI & Vaxxas' podcast here.

Other podcasts in the MTP Connect series can be found here.