VVMF Secures TGA GMP Licence For Sydney Facility

KUALA LUMPUR, Sept 10 (Bernama) -- Viral Vector Manufacturing Facility Pty Ltd (VVMF), Australia’s first viral vector contract development and manufacturing organisation (CDMO), has secured a licence to manufacture therapeutic goods (GMP licence) from the Therapeutic Goods Administration (TGA) for its Sydney facility.

VVMF said the licence authorises the good manufacturing practice (GMP) manufacture of replication-incompetent viral vectors using recombinant technology, as sterile active pharmaceutical ingredients (APIs) or sterile medicinal products, together with associated quality control (QC) testing.

VVMF chief executive officer, Stephen Thompson said the licence marked a defining moment for the company and an important milestone for Australia’s advanced therapeutics sector, enabling innovators to access viral vector manufacturing services locally.

According to a statement, the licence follows a comprehensive TGA assessment of VVMF’s facilities, quality systems, manufacturing operations and operational capabilities.

Located within Sydney’s Westmead Health and Innovation Precinct, the facility was established to strengthen Australia’s advanced therapeutics ecosystem by providing local viral vector manufacturing capabilities and reducing reliance on overseas suppliers.

VVMF said the facility supports clients developing gene therapies, genetically modified cell therapies and other advanced therapeutics requiring viral vectors, offering process development, analytical development, GMP manufacturing and QC testing services.

The company said the licence would expand access to advanced therapeutics manufacturing across Australia and the Asia-Pacific region, supporting biotechnology companies, researchers and therapy developers.

VVMF said its manufacturing capabilities could support programmes from early development through clinical translation, while Australia’s regulatory environment, clinical trial ecosystem and research and development tax incentives provide an attractive manufacturing base for local and international therapy developers.

The company said the TGA licence establishes a domestic manufacturing capability for viral vectors and strengthens Australia's position in the cell and gene therapy supply chain.

-- BERNAMA