Clinically Enabled Manufacturing
The NBF has a proven track record of working with our collaborators to develop programs through to Phase I clinical end points. The NBF also provides hands-on training in cleanroom bioprocess operations in a simulated GMP environment.
NBF has established equipment platforms and process models at each node to enable efficient tech transfer and scale-up from shake flask up to 200L bioreactor scale, offering affordable production services whatever your application or material volume and quality requirements.
Scalable up to 200L
Through the Victorian node, the NBF is on track to bring online a new purpose-built cGMP facility in late 2021, with 200L mammalian production scale to generate drug substance for bulk fill or for limited (up to 300 vials) drug product final formulation and fill services.
Drug Substance to Fill and Finish
We take a phase appropriate testing approach for each program to ensure the NBF can support release assays for Quality Assurance-issued Certificates of Analysis through to in-process or for-information-only characterisation results.
Full QC Release
The NBF through the NSW node, offers hands-on teaching and training experiences delivering training programs from the Dublin-based National Institute of Bioprocessing Research and Training (NIBRT).