Australian biologics manufacturer BioCina has plans to further develop its state-of-the-art facility to enable it to make the next generation of mRNA vaccines and other mRNA-based therapies possible.
Backed by Australian Government financial support, BioCina is partnering with the University of Adelaide and US-based Cytiva to speed RNA-based product development and make them more stable. This will accelerate progress to clinical trials for future vaccines and other diseases, including cancer.
‘There is a large unmet demand for high-quality manufacturing in the microbial space,’ says Ian Wisenberg, BioCina’s CEO. ‘With the support of our investors, the Bridgewest Group of Companies, we aim to step up to meet that need.’
BioCina is a full-service contract development and manufacturing organisation (CDMO). It specialises in process development and GMP manufacture of recombinant biological therapeutic products.
BioCina uses microbial cells to manufacture complex biological molecules, such as proteins and poly nucleic acids. These molecules typically cannot be made using conventional chemical synthetic methods. The biological molecules are made by fermenting then purifying from microbial cells (mainly E. coli). These products can be used in clinical trials or for commercial purposes.
‘Using microbial cells in manufacturing is cost-effective,’ says Wisenberg. ‘Manufacturing can be done at very large scale to make products at a low-cost point.’
BioCina manufactures a wide range of products for clients. They include recombinant whole-cell vaccines, recombinant proteins such as antibody fragments, and nucleases. It also makes cGMP-grade plasmid DNA and will soon be able to manufacture RNA products.
Wisenberg says Australia’s clinical trials and manufacturing expertise make the country a high-quality, cost-effective location to develop and manufacture new treatments.
‘Australia has a highly regarded clinical trials network that is known for rapid approval and completion of Phase I clinical studies,’ he says. ‘It makes sense to manufacture products close to the clinical trial site, and vice versa. It is much more cost-effective and efficient for the drug sponsor.’
In addition to simplifying the supply chain, Australia offers grants and incentives to conduct research and development here. The R&D Tax Incentive covers all R&D work including GMP manufacture and clinical trials. Australia also has a highly developed biomedical ecosystem offering opportunities to collaborate with world-leading experts.
BioCina’s Adelaide facility has a well-established history in the microbial manufacturing space. It was most recently owned and operated by Pfizer, and Hospira before that. The facility was upgraded in 2016 at a cost of $25 million and is now one of the premier facilities of its kind in the Oceania region. The facility is licensed for GMP manufacture by Australia’s Therapeutic Goods Administration and has been inspected by the US FDA.
‘It has manufactured a commercial product that is being marketed and sold in the US, Europe and Canada by Pfizer,’ says Wisenberg.
The facility offers full clinical supply services from early-phase clinical trials to commercialisation to biopharmaceutical customers. It is the only CDMO in the region with the capability and capacity to manufacture plasmid DNA in a GLP and GMP environment.
‘We are just eight months into this new facility and have already increased our headcount by over 25%,’ says Wisenberg. ‘We are looking to expand our footprint both locally and internationally.’
BioCina recently received a A$3 million grant through the Cooperative Research Centres Projects Grants scheme. The grant will fund work to address the post-pandemic demand for new mRNA products.
‘The market is looking for a more stable mRNA product that can be stored at temperatures of 2 to 8 degrees,’ says Wisenberg. ‘The market will also prioritise LNP formulations that optimise the delivery and therapeutic efficiency of the mRNA cargo. There will also be increasing demand for next-generation RNA constructs such as circular RNA that circumvent limitations of conventional first-generation mRNA products.’
BioCina’s partners in the project are the University of Adelaide and Cytiva. Researchers at the university will address the design and manufacture of lipid nanoparticles. They will also look at improving formulation to increase product stability. Cytiva will supply the mRNA manufacturing equipment at R&D and GMP scales.
‘The technological advancement developed by our research partners will allow mRNA drugs to be targeted to specific tissues,’ says Wisenberg. ‘The final product will also be stable at higher temperatures, making it easier to store and transport.
‘Together, we will establish the critical infrastructure to translate Australian research in mRNA, and other RNA-based therapeutic modalities, to the clinic.’
BioCina and its partners will also develop mRNA-based therapies to treat other disease types such as cystic fibrosis, heart disease, rare genetic conditions, and some cancers.
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