The National Biologics Facility (NBF) enables Australian researchers to identify and translate their biomedical research discoveries, bridging the gap between early-stage development, testing and clinical supply for next-gen therapeutic candidates.  The facility services academic and industry researchers utilising recombinant protein production in mammalian systems to advance therapeutic agents (biologics), candidate vaccines, and biomarkers for diagnostic development, under a dedicated quality management system certified to ISO 9001:2015.  

 

The NBF has broad capabilities ranging from early-stage discovery of new mammalian-cell culture based biotherapeutics through to the development-stage scale-up and establishment of manufacturing processes for Phase I material generation. Within the Australian biologics ecosystem, the NBF specialises in early-stage biopharmaceutical development including protein engineering, antibody discovery using phage display, transient protein production and purification and biophysical characterisation. For development of lead candidate biotherapeutics, NBF assists with manufacturing of Phase I material, through cell line development and clonal isolation, upstream and downstream bioprocess optimisation, analytical assay development and qualification to support release and stability analytics.  

 

The NBF boasts a successful track record in progressing researchers' biopharmaceutical drug candidates towards Phase I clinical end points and is able to manufacture drug substance for first-in-human clinical trials in Australia.