Viral Vector Manufacturing Facility Pty Ltd (VVMF) has received a Therapeutic Goods Administration (TGA) manufacturing licence for its Sydney facility, allowing the company to manufacture viral vectors under Good Manufacturing Practice (GMP) conditions.
VVMF, which describes itself as Australia’s first viral vector Contract Development and Manufacturing Organisation (CDMO), said that the TGA had granted its Westmead facility a Licence to Manufacture Therapeutic Goods.
In a media release, VVMF stated the licence authorises the GMP manufacture of replication-incompetent viral vectors using recombinant technology, including sterile active pharmaceutical ingredients (APIs) and sterile medicinal products, as well as associated quality control testing.
The company said the licence followed an assessment of its facilities, quality systems, manufacturing operations and operational capability against GMP requirements.
“Receiving our TGA Manufacturing Licence is a defining moment for VVMF and an important milestone for Australia’s advanced therapeutics sector,” VVMF CEO Stephen Thompson said.
“This achievement establishes a sovereign capability that will enable innovators to access world-class viral vector manufacturing services locally while supporting the growth of Australia’s cell and gene therapy ecosystem,” he said.
VVMF said its facility in Sydney’s Westmead Health and Innovation Precinct was established to provide local viral vector manufacturing capabilities for developers of gene therapies, genetically modified cell therapies and other advanced therapeutics.
The company said the facility is intended to reduce reliance on overseas suppliers and strengthen domestic manufacturing capability across the advanced therapeutics value chain.
VVMF provides process development, analytical development, GMP manufacturing and quality control testing services, according to the company. It said these capabilities are designed to support programs from early development through clinical translation.
Chief Quality Officer Maria Adesida said the TGA licence reflected the company’s manufacturing and quality systems.
“The granting of our TGA Manufacturing Licence demonstrates the strength of our quality systems, facility, operational controls and manufacturing capability,” Adesida said.
“This achievement reflects the expertise, dedication and commitment of our team in building these systems from the ground up and establishing a strong quality culture embedded in how we operate,” she said.
VVMF said the licence will allow it to provide GMP-compliant viral vector manufacturing services to Australian and international clients. The company also said it aims to expand access to advanced therapeutics manufacturing across Australia and the Asia-Pacific region.
According to VVMF, the facility could provide biotechnology companies, researchers and therapy developers with access to specialist viral vector manufacturing capabilities in Australia.
The company also cited Australia’s regulatory environment, clinical trial ecosystem and research and development tax incentives as factors supporting the country as a manufacturing destination for local and international therapy developers.
“The importance of this moment extends well beyond the licence itself,” Adesida said. “VVMF can now deliver GMP-compliant viral vector manufacturing services to our clients, enabling us to support the advancement of the next generation of cell and gene therapies.”
The TGA licence represents a regulatory milestone for VVMF, while the company’s stated expansion plans will determine how its newly licensed manufacturing capability develops across the Australian and Asia-Pacific advanced therapeutics sectors.
