CSIRO Opens Australia's New Biologics Manufacturing Facility for Clinical Trials


CSIRO's new National Vaccine and Therapeutics Lab follows a successful pilot facility in the early stages of the COVID-19 pandemic. ©  Copyright NICK PITSAS

With the completion of  CSIRO's National Vaccine and Therapeutics Lab in Melbourne, Australian SMEs and academics will for the first time be able to manufacture their biologics in Australia to prepare for human clinical trials.

This project was supported with $1.1 million in funding from MTPConnect's Growth Centre Project Fund in 2017, starting with the development of a business plan and progressed to support for the design of the laboratory and purchasing and installation of specialist equipment. The build of the facility was funded by CSIRO. The final stage of the project is to install and qualify the equipment and to complete the facility documentation.

Challenges and Solutions

The fundamental research in academic and SME laboratories is discovering biologics with the potential to address major unmet clinical needs, but the research must be translated to medical products to create impact. Australia is an attractive destination for clinical trials, with an excellent medical system and a streamlined regulatory system for Phase I trials (the TGA CTN scheme), however in the absence of a facility in Australia to manufacture biologics to the standard required for in-human studies, Australian researchers can struggle to overcome the 'valley of death', the gap between fundamental research and clinical trials.

For clinical trials, biologics must be produced in clean rooms, under GMP conditions, with robust Quality Control - and an overarching Quality Management System. There were no publicly available facilities in Australia that could manufacture biologics to the required quality for clinical trials beyond Phase I, hence the need for  CSIRO's National Vaccine and Therapeutics Lab.

MTPConnect worked with CSIRO, Monash University, Telix Pharmaceuticals, Sementis, CEPI, the Victorian State government and a SIEF grant to develop and fit out the Biomanufacturing facility at CSIRO's Clayton site.

With the advent of Covid-19, the need for biomanufacture for clinical trials became urgent: although  CSIRO's National Vaccine and Therapeutics Lab had not been completed, CSIRO was operating clean rooms for the manufacture of biologics derived from mammalian cell culture, and there was a robust Quality Management System in place, enabling manufacture to a quality required for Phase I clinical trials. Using these facilities, and staff trained in process development and GMP manufacture, CSIRO manufactured two Covid-19 vaccines for clinical trials purposes, one for the University of Queensland in 2020, and one for the University of Melbourne in 2021.

Serving Australia's biomedical industry

CSIRO's National Vaccine and Therapeutics Lab is the only facility available to SMEs and academics for GMP manufacture of Biologics from mammalian cell culture in Australia. The facility consists of a state-of the-art facility for manufacture of Investigational Materials for evaluation in human clinical studies and is supported by a robust Quality Management System. While building a dedicated Quality Control laboratory, the QC team is operating in a temporary facility, offering qualified and validated assays to support the GMP manufacture of biologics.

With a breadth of activities from research and development to manufacture, quality control, analytics, quality assurance, upstream and  downstream processing, bioconjugation and testing, and with products ranging from antibodies, protein-based vaccines, theranostics and more produced in mammalian and insect platforms, this facility is truly able to serve the needs of the biomedical industry.

What does it all mean?

With the completion of CSIRO's National Vaccine and Therapeutics Lab, Australian SMEs and academics will be able to manufacture their biologics in Australia. They will be able to engage closely with the scientists performing the process development and manufacture, facilitating transfer of their technology and enabling their Qualified Person to monitor the product quality at all stages of manufacture.

Manufacture in Australia will be faster and more cost effective than manufacture overseas, meaning more Australian discoveries make it to clinical trials and eventually to the clinic, leading to better health outcomes for all patients, and more value from Australian research captured in Australia.

With more trained scientists, and closer ties between universities, CSIRO and the local biotech industry, there will be greater potential to grow Australia's valuable medical technology and pharmaceutical sector.

CSIRO is Australia’s national science agency. Companies interested in working with the new facility should contact 1300 363 400.