The current global biologics market e.g. protein-based drugs, vaccines etc. is over US$200 billion, with sales expected to rise to US$400 billion by 2024. Currently, there are no Australian facilities available for the rapid and cost-effective production of clinical grade biologicals which are suitable for human trials worldwide. This compromises the development of potential blockbuster drugs arising from the Australian biomedical research sector and consequently causing significant loss in terms of financial, employment and intellectual property. CSIRO Manufacturing is creating a cGMP facility to provide a significant boost to advanced manufacturing and translational capabilities of research findings in hospitals, universities and biomedical institutes, together with the local SME community, into clinical development and, eventually, patient impact/benefit.
This new, flexible and multipurpose manufacturing facility will enable rapid and effective translation of biological discoveries into high-value clinical entities. Process development and large-scale production of biologicals (such as vaccines, monoclonal antibodies, antigens, growth factors, stem cells, etc.) under the most stringent regulatory (cGMP) standards will be available for biotech companies and academia. This will be a unique capability in the Australian landscape to remove a major rate-limiting step by providing novel, high-quality biological drugs for evaluation in pre-clinical and Phase-I human clinical trials in Australia and worldwide.
This seminar summarizes the capabilities of this facility and provides examples of our experience working with novel vaccine candidates via a collaborative partnership involving CEPI (Coalition for Epidemic Preparedness Innovations).