Vaxxas, a clinical-stage biotechnology company commercialising a novel vaccination platform technology, has announced the opening of its first, state-of-the-art manufacturing facility in Brisbane, Queensland.
The custom-built 5,500 sqm (60,000 sqft) Vaxxas Biomedical Facility will serve as the company’s global headquarters and support the scale-up of its operations to produce HD-MAP vaccines for future late-stage clinical trials and first commercial products.
The facility contains two independent Good Manufacturing Practice (GMP), qualified aseptic cleanrooms, a medical device manufacturing space, a device assembly cleanroom, and supporting infrastructure including laboratories and office space.
The facility also provides a blueprint for scalable product production processes that can potentially be replicated by Vaxxas domestically and globally as demand for its platform technology grows
The Queensland Government provided funding and operational support to Vaxxas in developing the facility. Vaxxas has received additional funding from the Australian Government through its Modern Manufacturing Initiative to support the installation of specialised manufacturing and production infrastructure. The facility represents a significant investment in the future of Queensland’s and Australia’s biotech sectors.
Queensland Deputy Premier, Minister for State Development, Infrastructure, Local Government and Planning and Minister Assisting the Premier on Olympic and Paralympic Games Infrastructure, The Honorable Dr Steven Miles officiated the opening.
“Queensland is fast shaping up as a global research and innovation hub thanks to the Palaszczuk Government’s investment in state-of-the-art facilities like this one. Economic Development Queensland worked closely with Vaxxas to progress designs and approval for this facility, so it’s fantastic to be here to open it,” Deputy Premier Steven Miles said.
Proprietary technology
Vaxxas’ proprietary HD-MAP technology platform has the potential to improve vaccination by creating vaccine products that are easy to use (potentially enabling self-administration) and can be stable at room temperature, reducing the complexities and costs associated with refrigerated distribution required for many existing vaccines.
Vaxxas CEO, David Hoey said the facility’s opening marked a significant milestone for the biotech company which was founded in 2011 on research from The University of Queensland.
“The Vaxxas Biomedical Facility represents a new and exciting chapter for our company, as it is foundational for our next phase of growth. With the support of the Queensland State and Australian Federal Governments, the Vaxxas Biomedical Facility will firmly position Australia at the forefront of vaccine technology innovation. The site will significantly increase our manufacturing capacity, creating new local, skilled jobs, while enabling Vaxxas to progress through late-stage clinical trials that will bring our first commercial vaccine products to the market,” said Hoey.
Vaxxas currently employs 130 people in its Queensland operations, and is planning for an increase to 200 employees over the next three to five years. The new facility will enable Vaxxas’ R&D teams to work side by side with manufacturing teams, to expand existing R&D work and streamline the translation from research to eventual commercialisation.
Manufacturing will be conducted in compliance with Good Manufacturing Practice (cGMP) standards
Manufacturing will be conducted in compliance with Good Manufacturing Practice (cGMP) standards which will also meet the requirements of the Australian Therapeutic Goods Administration, the United States Food and Drug Administration, the European Medicines Agency as well as other global health regulators.
With success in several completed human clinical trials involving more than 500 participants; additional ongoing Phase I clinical studies for COVID-19 and seasonal influenza; and other vaccine studies targeting pandemic influenza, funded by the United States Biomedical Advanced Research and Development Authority (BARDA), and a measles-rubella study funded by the Bill & Melinda Gates Foundation, expected to start in 2024, Vaxxas’ HD-MAP vaccine delivery platform is advancing rapidly toward commercialisation.
About Vaxxas’ HD-MAP technology
The Company’s proprietary HD-MAP technology platform utilises an ultra-high-density array of projections – invisible to the naked human eye – applied to the skin as a patch sitting inside a small applicator device. When applied to the skin, the patch delivers vaccine to the abundant immune cells immediately below the skin surface. This approach can enhance the efficiency and effectiveness of resulting immune responses of vaccines.
Vaxxas uses proprietary dry-coating technology to apply an active and stable vaccine onto the projections, which offers the potential to eliminate the need for vaccine refrigeration during storage and transportation – reducing the resource and logistics burden of maintaining the refrigerated “cold chain.” Ease of use of the HD-MAP could enable simplified administration, potentially encompassing self-administration.
Vaxxas has six clinical programs underway with multiple vaccines and partners. Among these programs the Vaxxas HD-MAP is currently being evaluated in Phase I human clinical trials for Covid-19 and seasonal influenza. In addition, Vaxxas is preparing for clinical evaluation of a pandemic influenza vaccine under contract with the United States Biomedical Advanced Research and Development Authority (BARDA).
With leading global health organisations investing in the company’s HD-MAP technology and programs, including the Bill and Melinda Gates Foundation, World Health Organization (WHO) and CEPI (Coalition for Epidemic Preparedness Innovations), Vaxxas is also working towards improving access to vaccines in hard-to-reach areas by simplifying vaccine distribution and administration.