Viral Vector Manufacturing Facility Pty Ltd (VVMF) is a publicly funded, independently operated commercial CDMO incorporated in New South Wales, Australia, and headquartered at Level 4, Kids Research, The Children’s Hospital at Westmead, 178 Hawkesbury Road, Westmead NSW 2145. The company is registered as an independent commercial entity with an independent Board and is funded by the NSW Government, reflecting Australia’s strategic intent to establish sovereign gene therapy manufacturing capability within the Asia-Pacific region.

VVMF is distinguished as Australia’s first commercial viral vector manufacturing facility, physically integrated within the largest health, education, research, and innovation precinct in the country — a co-location that provides direct access to a world-class clinical trial ecosystem, gene therapy clinical expertise, and translational research infrastructure. On 9 September 2026, VVMF received its TGA (Therapeutic Goods Administration) manufacturing licence, a milestone that formally enables the company to manufacture viral vectors to Australian GMP standards and supply clinical-grade material for regulated clinical trials.

The company is led by CEO Stephen Thompson, who brings senior operations and commercial leadership experience from Baxter International, Icon Group, and Nestlé. Scientific leadership is provided by Chief Medical Officer Prof. Ian Alexander PhD — a globally recognised pioneer in paediatric gene therapy at the University of Sydney and The Children’s Hospital at Westmead — and Chief Technology Officer Prof. Leszek Lisowski PhD, a world vectorology expert with over 20 years of experience in viral vector development, manufacturing, and translation, and the founder of the Translational Vectorology Research Unit at the Children’s Medical Research Institute (CMRI). The Board is chaired by Sue MacLeman, a pharmaceutical and health technology executive with over 30 years of senior industry experience.

VVMF’s commercial strategy targets gene therapy sponsors across Australia, the Asia-Pacific region, and globally, positioning itself as a regional catalyst for viral vector innovation and a commercial-scale manufacturing partner for advanced therapeutic programmes.

Key Products and Services

Lentiviral Vector (LV) Manufacturing

• Clinical construct design consultation
• Research grade and toxicology grade lentiviral vector production
• cGMP Master Cell Bank (MCB) and Working Cell Bank (WCB) manufacture
• Pilot-scale optimisation and manufacturing
• Clinical manufacturing for Phase I/II programmes up to 500L scale

AAV (Adeno-Associated Virus) Vector Manufacturing

• Research grade and toxicology grade AAV production across serotypes
• cGMP cell bank manufacture
• Pilot-scale AAV process optimisation
• Clinical manufacturing for Phase I/II programmes

Process and Analytical Development

• Viral vector research and development
• Analytical assay development and implementation, including potency, identity, purity, and safety testing methods
• Upstream and downstream process development and scale-up optimisation

Scientific and Strategic Consultation

• Clinical construct design consultation for sponsors at early programme stages
• Technical and feasibility discussions for new viral vector programme requirements
• Partnership and strategic discussion engagement for regional and international sponsors

VVMF occupies a structurally unique position in the Asia-Pacific CDMO landscape as the only commercially licensed viral vector manufacturer in Australia, at a time when global gene therapy manufacturing capacity remains a significant constraint and when the Asia-Pacific region — and Australia specifically — has been identified as a priority investment market for advanced therapeutic development. The company’s integration within The Children’s Hospital at Westmead and its scientific leadership from the CMRI gene therapy programme provides a translational research-to-clinic connectivity that is rare in the commercial CDMO space, and which is directly relevant to sponsors developing paediatric and rare disease gene therapies, where the proximity of clinical expertise and manufacturing capability within a single precinct is operationally advantageous. The TGA manufacturing licence awarded in September 2026 is a foundational regulatory milestone that establishes VVMF as a credible GMP manufacturing partner for clinical trial material supply, and its signed Letter of Intent with Optosleep in August 2026 represents its first disclosed commercial client engagement — an early but meaningful signal of commercial traction. NSW Government funding and an independent Board provide financial stability and governance structure appropriate for an organisation whose long-term strategic rationale is as much about Australian sovereign biomanufacturing capability as it is about commercial revenue generation.