Vaxxas has received a manufacturing licence from Australia’s Therapeutic Goods Administration (TGA) for its high-density microarray patch (HD-MAP) for clinical studies at a biomedical facility in Brisbane.
This development follows the installation of the company’s first robotic lines for aseptic (sterile) production.
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The HD-MAP is tailored to deliver all types of vaccines to the skin using a simple applicator, with the aim of providing a universal solution for self-administration of a vaccine.
The licence enables Vaxxas and its worldwide partners to advance vaccine delivery.
It covers aseptic manufacturing and incorporates principles and procedures, ensuring the produced vaccines meet the quality standards set by the Australian regulator and Good Manufacturing Practice (GMP) guidelines.
According to the company, the HD-MAP consists of several microscopic projections that are moulded into a tiny patch, each printed with a dried formulation of a small vaccine dose.
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By GlobalDataOn applying to the skin, it is said to deliver the vaccine to immune cells located just beneath the skin’s surface.
Vaxxas said that the patch has been administered to over 750 participants in early-stage clinical studies.
Six first-in-human studies have so far been completed by the company with support from the US Government, SK bioscience, Wellcome Trust, and the Gates Foundation.
These trials evaluated the HD-MAP’s potential to deliver vaccines against Covid-19, pre-pandemic and seasonal influenza, rubella, and measles.
The company noted that vaccines delivered via the Vaxxas HD-MAP remain under investigation and are available only for investigational purposes.
Vaxxas’ chief technology officer Dr Angus Forster said: “This licence unlocks the way forward for Vaxxas to continue developing our world-leading HD-MAP technology.
“We are proud to contribute to Queensland’s growing biotech sector and to advance sovereign manufacturing capabilities that translate cutting-edge research to address real-world health solutions.”
