- Viral Vector Manufacturing Facility Pty Ltd (VVMF) has received a Licence to Manufacture Therapeutic Goods from Australia’s Therapeutic Goods Administration (TGA) for its Sydney facility.
- The licence authorizes GMP manufacturing of replication-incompetent viral vectors using recombinant technology, as sterile APIs or sterile medicinal products, along with associated QC testing.
Viral Vector Manufacturing Facility Pty Ltd (VVMF) has received a Licence to Manufacture Therapeutic Goods, or GMP licence, from Australia’s Therapeutic Goods Administration (TGA) for its Sydney manufacturing facility. The license enables VVMF to manufacture viral vectors under GMP conditions for Australian and global clients developing advanced therapeutic products.
The licence authorizes the GMP manufacture of replication-incompetent viral vectors using recombinant technology. These can be manufactured as sterile active pharmaceutical ingredients (APIs) or sterile medicinal products, together with associated quality control testing. The licence follows an assessment of VVMF’s facilities, quality systems, manufacturing operations and operational capability.
The facility is located within Sydney’s Westmead Health and Innovation Precinct and was established to provide local viral vector manufacturing capabilities for the cell and gene therapy sector. VVMF said the facility is intended to reduce reliance on overseas suppliers and strengthen domestic capabilities across the advanced therapeutics value chain.
VVMF provides services covering process development, analytical development, GMP manufacturing and quality control testing. The facility supports clients developing gene therapies, genetically modified cell therapies and other advanced therapeutics that require viral vectors, with services spanning early development through clinical translation.
“Receiving our TGA Manufacturing Licence is a defining moment for VVMF and an important milestone for Australia’s advanced therapeutics sector. The licence establishes a sovereign capability for local viral vector manufacturing and supports the development of Australia’s cell and gene therapy ecosystem.”
Stephen Thompson, VVMF CEO
