Posted: 24 September 2025
CBE Pure Solutions has received expanded licence from the Therapeutic Goods Administration (TGA). Their TGA licence now includes sterile fill-and-finish and labelling for injectables and infusions for all clinical trial phases (1-3).
In addition, CBE Pure Solutions were able to gain manufacturing licensing for commercial non-sterile registered therapeutic liquids. These new capabilities build on their existing TGA licence for microbiology and sterility testing.
CBE Pure Solutions says, the TGA licence recognises a state-of-the-art facility in Melbourne meets the highest standards for aseptic manufacturing. The BioMelbourne Network member is the only contract manufacturer (CMO) in Australia with licensed world-leading isolator systems, with its enclosed vaporised hydrogen peroxide decontamination cycles, for sterile manufacturing and testing. This advanced technology complements CBE Pure Solutions Australian-first rapid microbiology testing, which allows batch release in three days, rather than the usual 14 days.
This licence expansion is a major milestone in the company’s journey – a testament to the strength of their quality systems, their expert team, and commitment to nimbleness and compliance, without compromising patient safety.
The company says, it is excited to support local and global partners along their drug development pipeline with its premium, yet nimble, sterile GMP services.
About CBE Pure Solutions:
CBE Pure Solutions is an Australian-owned specialised therapeutic contract manufacturing organisation (CMO), established in 2021. The company focuses on delivering expert sterile fill-and-finish and microbiological testing services.
Its purpose-built modular facility in Melbourne’s east has been specifically designed to maintain Good Manufacturing Practice compliance (cGMP), whilst being nimble for small-scale clinical trial batches. CBE Pure Solutions also hold US FDA establishment registration, APVMA veterinary manufacturing approval, Victoria DHHS poisons licences, OGTR certification for GMO handling, and biosecurity clearances.
