CBE has many years hands on experience in support of biologics and sterile operations in vaccines, protein therapies, advanced therapies and plasma products. Our combined experience across compliance, aseptic processing, microbiology, cleanroom management, advance therapies processing, contamination control and validation to PICs, TGA and FDA standards allows us to bring our unique expertise to these projects. Our experience crosses green-field start-ups, clinical trials, remediations, gap analysis and commercial operations.
CBE Partners have all worked in the pharmaceutical space for many years at senior levels across operations, quality, compliance, regulatory, clinical, cleanrooms and engineering/validation. We are able to bring our extensive technical and project experience to any project. CBE also supports the Australian compounding industry in the areas of cleanroom design, facility upgrades, validation and GMP licensing.
CBE Partners have supported the Medical Device Industry across specific projects for many years. Our projects include diagnostics, implants, 3D-printed devices amongst others. We assist client in ISO13485 /CFR 820 accreditations and quality system builds.
CBE experts support the industry sector to design or renovate facilities appropriate for aseptic operations, ensuring patient and operator safety, and compliance to national and international industry guidelines).
CBE supports emerging therapies, both technically and strategically, such as Fecal Microbiome Transplants (FMT), Immunotherapies, Exosomes, including containment strategies and technical and compliance solutions for operations.