Clinical Manufacturing Training Hub Accelerates Research Translation

Pictured: Translational Research Institute (TRI)'s Director of Building Operations Michelle Richards with Minister for Industry, Science and Technology Hon. Karen Andrews MP and others on a tour of the cleanroom facility in Brisbane in 2019. Photo by Glenn Hunt Photography.

A clinical manufacturing training hub set up by The Translational Research Institute (TRI), in collaboration with VAXXAS, PharmOut & Eurofins AMS is enabling the translation of innovative, investigational products into clinical studies. This work is conducted through the MTPConnect Project Fund Program, funded by the Department of Industry, Science, Energy and Resources (DISER).

The project establishes a "turn-key" early stage clinical product manufacturing facility to Good Manufacturing Practice (GMP) standard for a wide-range of clean to sterile, biological, pharmaceutical, device and medtech products at the dedicated site at the TRI in Brisbane.

The collaborators designed the project to solve two main barriers in translating innovations to industry and the clinic:

  1. Providing access to high quality GMP standard cleanrooms with small scale manufacturing capabilities.

The consortium observed that Australian researchers and start-up medtech and pharma companies had very limited access to high value infrastructure such as GMP cleanrooms. Many start-ups require time to develop their processes within these facilities and then to manufacture small scale product for use in clinical trials. This project aimed to provide that infrastructure and the quality management systems to operate and accelerate the translational pathway.

2. Access to facilities where staff can be trained in cleanroom technologies.

Australia has a workforce skills shortage in cleanroom processes and advanced manufacturing in the medtech, biotech and pharma industries.

Pictured: Researchers utilising the cleanroom facilities at the TRI in Brisbane.

While the TRI facility is not being used for small scale manufacture, it is training researchers and students in cleanroom operations, giving them transferable skills and further career options.

TRI CEO Professor Scott Bell said the establishment of the cleanroom in 2017 has been important to provide training to researchers that builds their skills.

“MTPConnect’s support ensures that more Queensland innovations make it to the clinic and that the new generation of scientists learn valuable skills in product development and advanced manufacturing,” Professor Bell explained.

“The TRI cleanroom and small-scale manufacturing facility fills the gap from the lab to the clinic, enabling discovery, production, and clinical trials and treatment to be available in one place.”

The TRI facility was completed in April 2020 and there has been a high interest for both training and clinical manufacturing. A training synopsis has been developed between Vaxxas and the TRI to provide a general introduction to the medtech development lifecycle as well as more specific hands-on based competency around the new cleanroom equipment. Since opening, the facility has trained 60 University of Queensland Masters of Pharmacy students so far. 

Vaxxas is an Australian biotechnology company, based at the TRI, that is developing and commercialising vaccine delivery technologies such as their innovative Nanopatch™

Vaxxas CEO David Hoey said the partnership with TRI and the other consortium members, are enabling Australian researchers and start-ups to access these facilities that have never been available before in early stage research.

“The MTPConnect-supported Cleanroom Upgrade Project has increased the level of compliance and flexibility of the cleanrooms at the Translational Research Institute,” Mr Hoey added.

“This has enabled Vaxxas to manufacture, in-house, sterile clinical trial material for a number of Phase I clinical studies.

“The upgraded cleanrooms and state-of-the-art manufacturing equipment, coupled with trained TRI staff and the Quality Management System (QMS) templates provide an easily accessed and flexible early stage clinical trial manufacturing and training facility.”

For more information, visit Translational Research Institute.

You can also hear more about this project from TRI’s Michelle Richards and Vaxxas’s Charles Ross, on the MTPConnect Podcast Series now.