TGA grants licence to Australia’s first viral vector manufacturing facility

The Therapeutic Goods Administration (TGA) has granted Viral Vector Manufacturing Facility (VVMF), Australia’s first viral vector contract development and manufacturing organisation (CDMO), a GMP licence for the Sydney facility.

This milestone is significant for Australia’s rapidly growing cell and gene therapy sector, enabling VVMF to manufacture viral vectors under GMP conditions to support the development and commercialisation of advanced therapeutic products for Australian and global clients.

Stephen Thompson, CEO of VVMF, said “Receiving our TGA Manufacturing Licence is a defining moment for VVMF and an important milestone for Australia’s advanced therapeutics sector. 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, ultimately, helping bring these therapies closer to the patients who need them.”

The licence authorises the GMP manufacture of replication-incompetent viral vectors using recombinant technology, as either sterile Active Pharmaceutical Ingredients (APIs) or sterile Medicinal Products, together with associated Quality Control (QC) testing.

The company’s manufacturing facility, located within Sydney’s Westmead Health and Innovation Precinct, was established to strengthen Australia’s advanced therapeutics ecosystem by providing local access to high-quality viral vector manufacturing capabilities. It reduces reliance on overseas suppliers and strengthens domestic capability across the advanced therapeutics value chain.

Maria Adesida, Chief Quality Officer at VVMF, stated “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. The importance of this moment extends well beyond the licence itself. 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 facility supports clients developing gene therapies, genetically modified cell therapies and other advanced therapeutics requiring viral vectors. By providing end-to-end process development, analytical development, GMP manufacturing and quality control testing services, VVMF is positioned to support programs from early development and throughout their clinical translation journey across Australia and the Asia-Pacific region.

The company recently partnered with UNSW-based startup Optosleep on the evaluation and development of an adeno associated virus (AAV)-based optogenetic gene therapy program as a potential treatment for obstructive sleep apnoea (OSA).

VVMF is a registered independent commercial entity, with an independent Board, funded by the NSW Government.

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