CBE Pure Solutions
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…
Services
- Microbiological Testing
Overview
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 Module and line utilises isolator technology for small scale boutique filling of specialist products with capability of vials and syringes from 1ml to 20ml.
A larger facility for Phase 2 and 3 clinical trials is under construction and anticipated licensing later in Q1, 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 2279).