Australian biotechnology company Vaxxas has been granted a Therapeutic Goods Administration licence to manufacture therapeutic goods, clearing the way for GMP-compliant manufacturing at its Brisbane biomedical facility and supporting the progression of clinical trials for its proprietary high-density microarray patch technology.
In a media release, Vaxxas said the licence allows Vaxxas to undertake aseptic manufacturing of its HD-MAP products for clinical trials, following the installation of its first robotic manufacturing lines.
According to the company, the approval positions its Brisbane site to produce sterile products in line with TGA and Good Manufacturing Practice requirements, supporting ongoing development and scale-up activities.
Vaxxas Chair Sarah Meibusch said the manufacturing approval represents a key step in the company’s development pathway.
“The TGA manufacturing licence marks a significant milestone for Vaxxas as we progress toward commercialising our HD-MAP technology,” Meibusch said.
“By reducing cold-chain requirements and enabling self-administration, this innovation addresses key barriers to vaccine access and uptake worldwide.”
Chief Technology Officer Dr Angus Forster said the licence supports both product development and local manufacturing capability.
“This licence unlocks the way forward for Vaxxas to continue developing our world-leading HD-MAP technology,” Forster said.
“We are proud to contribute to Queensland’s growing biotech sector and to advance sovereign manufacturing capabilities that translate cutting-edge research into real-world health solutions.”
Vaxxas said the HD-MAP is designed to deliver a range of vaccine types to the skin using a single-use applicator, with the potential to simplify vaccine delivery and support broader access.
