TGA grants VVMF licence to manufacture viral vectors for cell and gene therapies

Australia’s first specialist viral vector contract development and manufacturing organisation has secured a regulatory licence for its Sydney facility to support the development of cell and gene therapies.

Viral Vector Manufacturing Facility (VVMF) has received a Licence to Manufacture Therapeutic Goods from Australia’s medicines regulator the Therapeutic Goods Administration (TGA). The authorisation will strengthen Australia’s domestic capacity to manufacture essential components for advanced therapies.

The company, which describes itself as Australia’s first viral vector contract development and manufacturing organisation, has secured authorisation to manufacture viral vectors under the internationally recognised standard of Good Manufacturing Practice (GMP) conditions. The licence supports its work with Australian and international clients to develop and commercialise advanced therapeutic products.

Viral vectors act as delivery vehicles to transfer genetic material into cells. In gene therapies, that material can provide instructions intended to address disease or alter cell function. Vectors also support the manufacture of some genetically modified cell therapies, in which cells undergo modification before administration to patients. These approaches have applications in cancer, rare diseases and other conditions.

The licence authorises VVMF to manufacture replication-incompetent viral vectors through recombinant technology, which allows genetic material to be assembled or modified for a therapeutic purpose. These vectors are designed so that they cannot independently reproduce in their target cells.

The authorisation covers manufacture as either sterile active pharmaceutical ingredients, the active components of therapeutic products, or sterile medicinal products. It also encompasses associated quality control tests to assess whether material meets the required specifications.

GMP requirements provide a framework for consistent manufacture and quality control, including production processes, facilities and documentation. The TGA granted the licence after a comprehensive assessment of VVMF’s facilities, quality systems and operational capabilities.

Based in Sydney’s Westmead Health and Innovation Precinct, the facility was established to strengthen Australia’s advanced therapeutics sector through local access to specialist viral vector services. Domestic capacity can reduce reliance on overseas suppliers and provide an Australian option for an important stage of therapeutic development and manufacture.

“This achievement establishes a sovereign capability that will enable innovators to access world-class viral vector manufacturing services locally,” said Stephen Thompson, chief executive officer of VVMF.

He described the licence as an important milestone for Australia’s advanced therapeutics sector. He said local services would support the growth of the country’s cell and gene therapy sector and help bring therapies closer to patients.

The company has also sought to broaden access to advanced therapeutics manufacture across Australia and the Asia-Pacific region. It said its facility offered biotechnology companies, researchers and therapy developers specialist services within a geopolitically stable jurisdiction.

“The granting of our TGA Manufacturing Licence demonstrates the strength of our quality systems, facility, operational controls and manufacturing capability,” said Maria Adesida, chief quality officer at VVMF.

She said the achievement reflected the team’s expertise and commitment to establish those systems and embed a strong quality culture throughout the organisation.

“VVMF can now deliver GMP-compliant viral vector manufacturing services to our clients,” she added. She said this capability would support progress towards the next generation of cell and gene therapies.