The grant has been awarded by the Australian Government’s National Health and Medical Research Council (NHMRC), and will be matched by the South Australian Government to support a five-year collaborative project with a total value of over $10.0m AUD, working with industry and academic partners, Cytiva and the University of Adelaide.
The project, commencing almost immediately, helps BioCina address the post-pandemic mRNA demand for specific and essential attributes of new personalized RNA products. Australia currently lacks domestic manufacturing of mRNA products under accredited pharmaceutical GMP. This MRFF grant strengthens linkages between commercial lead BioCina Pty Ltd, industry partner Cytiva, as well as expands discovery research in microfluidic chip parallel manufacturing of mRNA based therapeutic vaccines with world-class experts from the University of Adelaide. Outcomes of this grant will extend mRNA manufacturing and analytical capabilities of BioCina’s GMP facility to all clinical phases and commercial supply and deliver new to market automated microfluidics technology for manufacture of mRNA therapeutic vaccines, which will fill a significant technology gap in the personalised mRNA vaccines market.
“I’m very proud that BioCina has earned this MRFF grant. This funding, along with additional financial support from the South Australian Government, aims to deliver two complementary outcomes. The first is an increase in mRNA manufacturing and associated analytical capability at BioCina, and the second is a microfluidics-based device for parallel manufacture at the small scales required for the personalized therapeutic vaccines market. This will increase capacity to produce mRNA pharmaceuticals, including vaccines, from initial fermentation of DNA plasmids to formulated mRNA-Lipid Nanoparticle (LNP) complexes for administration in clinical trials,” said BioCina CEO, Mark W. Womack.
BioCina Executive Chairman and Founder, Ian Wisenberg added “This project increases capacity to produce mRNA-LNP at the BioCina site, as well as add end-to-end capacity to manufacture mRNA products. This expansion of manufacturing capabilities allows BioCina to service a larger section of the global market and ensure that Australia has population-scale onshore mRNA vaccine manufacturing capabilities.”
The University’s Deputy Vice Chancellor and Vice-President (Research), Professor Anton Middelberg commented “although ambitious, the research and development project has been carefully designed with a reasonable feasibility/gain/risk balance and it is strongly supported by the unique interdisciplinary and complementary expertise of the chief investigators (CIs). The proposed research is very closely aligned with the CIs’ expertise. The goal of this work is to introduce a start-to-finish manufacturing solution for personalised mRNA-LNP therapeutics that is world-class, in a timely manner that can service Australian and international companies.”
The Hon. Nick Champion, Minister for Trade and Investment, South Australian Government says, “BioCina’s mRNA Centre of Excellence in South Australia will be Australia’s first mRNA capability able to offer end-to-end client services to support the entire mRNA manufacturing and development process. We’re delighted to support BioCina’s manufacturing leadership and Australia’s sovereign mRNA vaccine supply capabilities.”
BioCina Pty Ltd. is a multi-service biologics contract development and manufacturing organization (CDMO), focused on the development and cGMP manufacture of microbial-based biological pharmaceuticals, including proteins, plasmid DNA, mRNA, vaccines and biosimilars, from early development through to commercialization. The BioCina Adelaide facility, formerly the Pfizer/Hospira plant, includes fit for purpose spaces for GMP manufacturing, process development, warehouse, and administration. The team has extensive experience and proven capabilities in microbial process development and manufacturing, with expertise from early process development to commercial manufacturing. BioCina has an enviable history manufacturing biological products approved for commercial use by the US-FDA, EMA and Health Canada, including the manufacturing of API for use in all stages of clinical trials. Licensed for GMP manufacture by the Australian Therapeutic Goods Administration (TGA), BioCina is the only GMP manufacturing facility of its kind in Australia that has successfully passed a US-FDA inspection.
Mark W. Womack, CEO BioCina: email@example.com / AUS: +61 429 111 363; US: +1 (619) 252-2537