- Contract Manufacturing Organisation (CMO)
- Contract Research Service
CBE Pure Solutions is an Australian GMP contract manufacturing organisation (CMO) focused on sterile fill-and-finish services, with complementary microbiology testing on-site.
CBE Pure Solutions operates from a state‑of‑the‑art, purpose‑built facility in Melbourne. It is fully cGMP‑licensed by the Therapeutic Goods Administration (TGA) and designed to meet international compliance standards for patient safety. Under our TGA licence we can manufacture any sterile liquids, for injectables and infusion, for all phases of clinical trials (I-III).
We have introduced Australia’s first qualified isolator technology for sterile manufacturing and microbiological testing. Our facility holds multiple critical regulatory approvals, including TGA cGMP licensing, US FDA establishment registration, APVMA veterinary manufacturing, Victoria DHHS poisons licenses, OGTR certification for GMO handling and biosecurity clearances.
We are the only CMO facility in Australia offering sterile fill-and-finish in our state-of-the-art isolators in PC2 clean rooms, so we can dispense biological therapies, including vaccines, monoclonal antibodies, phages, mRNA and gene therapies. Our team is highly experienced with GMP best practices, and we work with our clients on phase-appropriate controls to ensure patient safety.
CBE Pure Solutions has an extremely experienced leadership team with deep pharmaceutical industry that can help our clients’ to manufacture small-batches for clinical trials with our agile, high‑quality and compliant sterile services.
Services & Capabilities
- Sterile Liquid Manufacturing for Clinical Trial Materials (Phases I–III) – using advanced isolator technology, tailored to meet small‑run demands for early‑stage clinical testing of injectables and infusions.
- Microbiological Testing & Environmental Monitoring – comprising sterility testing, microbial limit testing, endotoxin assessments, and environmental monitoring for both inputs and finished goods.
- Support Services – include manufacturing support, encompassing materials sourcing, procurement, validation, analytical testing, stability studies, and access to consulting through CBE for facility design and strategic planning.
- Commercial Contract Manufacturing – offering aseptic fill and finish capabilities, including sterile and low‑bioburden processing in vials and syringes.
