CBE
CBE is Australia's leading biopharmaceutical consultancy, providing strategic solutions, expert training, and technical services across the product lifecycle. Headquartered in Melbourne with regional offices, CBE specializes in Quality, Engineering, Manufacturing, Supply Chain, R&D, Compliance, and Commercialization, supporting clients in biologics, blood products, ATMPs, vaccines, APIs, drugs, sterile products, diagnostics, and medical devices. The company is committed to enabling client success through high-quality, compliant, and innovative biopharmaceutical solutions.
Industries
Nr. of Employees
small (1-50)
Products
GMP Uplift Essentials program
A multi-day practical course for new entrants to GMP providing foundational principles, case studies and hands-on workshops in regulated manufacturing practice.
GMP Uplift Advanced program
An in-depth program for professionals with GMP experience covering advanced topics in compliance and practice application.
GMP Uplift Essentials program
A multi-day practical course for new entrants to GMP providing foundational principles, case studies and hands-on workshops in regulated manufacturing practice.
GMP Uplift Advanced program
An in-depth program for professionals with GMP experience covering advanced topics in compliance and practice application.
Services
Strategic and operational consulting across quality, engineering, manufacturing operations, supply chain, R&D, translation, due diligence and commercialisation.
Audit execution, regulatory gap analysis, PQS design and inspection readiness to support licensing and ongoing compliance.
Design input for facility concepts, cleanroom classification, critical services and commissioning support for regulated manufacturing environments.
Validation master planning, execution programs, media fill design, disinfectant validation and qualification of equipment and systems.
Structured GMP curriculum for new entrants and advanced professionals, including experiential hands-on cleanroom workshops and flexible virtual delivery.
Five-day inspection readiness programs with simulated regulatory interviews and practical preparedness training.
Strategic and operational consulting across quality, engineering, manufacturing operations, supply chain, R&D, translation, due diligence and commercialisation.
Audit execution, regulatory gap analysis, PQS design and inspection readiness to support licensing and ongoing compliance.
Design input for facility concepts, cleanroom classification, critical services and commissioning support for regulated manufacturing environments.
Validation master planning, execution programs, media fill design, disinfectant validation and qualification of equipment and systems.
Structured GMP curriculum for new entrants and advanced professionals, including experiential hands-on cleanroom workshops and flexible virtual delivery.
Five-day inspection readiness programs with simulated regulatory interviews and practical preparedness training.
Expertise Areas
- GMP compliance and audit readiness
- GMP training and workforce development
- Sterile aseptic processing and sterility assurance
- Facility and cleanroom engineering
Key Technologies
- Isolator-based closed aseptic processing
- Cleanroom design and HVAC for containment
- Environmental monitoring and air visualisation
- Media fill and microbiological validation
News & Updates
CBE has relocated to Jumar Bioincubator in Melbourne, joining a vibrant biotech community.
Participants of CBE's GMP training programs have benefited from specialized training, enhancing Australia's manufacturing capabilities.
Rachel Jensen presented on strengthening sovereign capabilities in biopharma at BioBriefing.
Steve Williams chaired a session on manufacturing mRNA and regenerative medicines at ARCS Australia 2022.
CBE's GMP training programs, supported by the REDI initiative, aim to upskill the Australian biopharma workforce.
CBE launched a new website to better connect with clients and showcase projects.
CBE has relocated to Jumar Bioincubator in Melbourne, joining a vibrant biotech community.
Participants of CBE's GMP training programs have benefited from specialized training, enhancing Australia's manufacturing capabilities.
Rachel Jensen presented on strengthening sovereign capabilities in biopharma at BioBriefing.
Steve Williams chaired a session on manufacturing mRNA and regenerative medicines at ARCS Australia 2022.
CBE's GMP training programs, supported by the REDI initiative, aim to upskill the Australian biopharma workforce.
CBE launched a new website to better connect with clients and showcase projects.