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The facility contains two independent GMP, qualified aseptic cleanrooms, and a medical device manufacturing space.
June 19, 2023
By: Anthony Vecchione
Vaxxas, a clinical-stage biotechnology company commercializing a novel vaccination platform technology, opened its first, state-of-the-art manufacturing facility in Brisbane, Queensland. The 60,000 sq.-ft. 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 Queensland Government provided funding and operational support to Vaxxas in developing the facility. Vaxxas’ 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 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 commercialization. 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. 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. David Hoey, CEO Vaxxas 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,” said Hoey. “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.” In a statement, the company said that 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.
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