CBE Pure Solutions (CBEPS) is an Australian based Contract Manufacturing Organisation (CMO), supporting Biotech and Pharmaceutical companies in the translation of Life Science products. Specialising in sterile fill and finish and microbiological testing.
Established 2021, CBEPS expertise lies in providing fill and finish services and microbiological testing services. CBEPS operate a state-of-the-art facility in Melbourne’s South East Biotech precinct, designed for Good Manufacturing Practice (cGMP) compliance and international standards. The company specialises in fill and finish services for liquid medicinal products and medical devices, offering comprehensive monitoring and testing services, including environmental monitoring and sterility testing.
The Clinical trial facility is Australia's only contract manufacturing facility utilising isolator technology for small scale boutique filling of specialist advanced therapy and traditional small molecule products with capability of vials and syringes from 1ml to 20ml. Licensing for Phase 2 and 3 clinical trials is anticipated in June, 2025.
The facility works to cGMP across all modules and holds TGA accreditation for laboratory testing and Quality systems (Licence MI-2023-08205-1) and Animal Health APVMA (Licence 1126).
Why work with us
- Speed and Expertise: Accelerate your projects with industry-leading capabilities in formulating and filling biologics, small molecules, mRNA, phage, and high-potency molecules.
- Unmatched Technology: Leverage Australia’s exclusive TGA-licensed isolator technology for state-of-the-art sterility assurance, processing 1,500 vials per day—perfect for medical devices and biologics.
- Compliance: Operate with confidence under TGA (EMA), supported by OGTR certification for handling GMOs and imported biological materials.
