Australian biologics maker BioCina plans to further develop its state-of-the-art facility to enable it to enable the next generation of mRNA vaccines and other mRNA-based therapies.
Backed by financial support from the Australian government, BioCina is partnering with the University of Adelaide and the American company Cytiva to accelerate the development of RNA-based products and make them more stable. This will accelerate progress in clinical trials for future vaccines and other diseases, including cancer.
“There is significant unmet demand for high-quality manufacturing in the microbial space,” says Ian Wisenberg, CEO of BioCina. “With the support of our investors, the Bridgewest Group of Companies, we aim to meet this need.”
Manufacturing based on a microbial platform
BioCina is a full-service contract development and manufacturing organization (CDMO). It specializes in process development and GMP manufacturing of recombinant biological therapeutics.
BioCina uses microbial cells to manufacture complex biological molecules, such as proteins and polynucleic acids. These molecules generally cannot be made using conventional chemical synthesis methods. Biological molecules are made by fermentation and then purification from microbial cells (essentially 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 on a very large scale to make products at low cost.”
BioCina manufactures a wide range of products for its customers. They include recombinant whole cell vaccines, recombinant proteins such as antibody fragments and nucleases. It also manufactures cGMP grade plasmid DNA and will soon be able to manufacture RNA products.
A high quality and profitable manufacturing site
Wisenberg says Australia’s clinical trials and manufacturing expertise make the country a high-quality, cost-effective place to develop and manufacture new treatments.
“Australia has a highly regarded clinical trials network known for the 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’s 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 manufacturing and clinical trials. Australia also has a highly developed biomedical ecosystem offering opportunities to collaborate with world-renowned experts.
A full-service manufacturing facility
BioCina’s Adelaide facility has an established history in microbial manufacturing. It was 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 first such facilities in the Oceania region. The facility is approved for GMP manufacturing by the Australian Therapeutic Goods Administration and has been inspected by the US FDA.
“He made a commercial product that is marketed and sold in the United States, Europe and Canada by Pfizer,” says Wisenberg.
The facility offers comprehensive clinical supply services, from early phase clinical trials to commercialization to biopharmaceutical customers. It is the only CDMO in the region with the capability and ability to manufacture plasmid DNA in a GLP and GMP environment.
“We’re only eight months into this new facility and have already increased our headcount by more than 25%,” says Wisenberg. “We are looking to expand our footprint both locally and internationally.”
Manufacturing the next generation of mRNA vaccines
BioCina was recently awarded an AU$3 million grant under the Cooperative Research Centers Projects Grants program. The grant will fund work to meet 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 prioritize LNP formulations that optimize the delivery and therapeutic efficacy of the mRNA cargo. There will also be an increasing demand for next-generation RNA constructs such as circular RNA that circumvent the limitations of conventional first-generation mRNA products.
BioCina’s partners in the project are the University of Adelaide and Cytiva. University researchers will focus on the design and fabrication of lipid nanoparticles. They will also seek to improve the formulation to increase product stability. Cytiva will provide mRNA manufacturing equipment at R&D and GMP scales.
“The technological breakthrough developed by our research partners will allow mRNA-based 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 build the essential infrastructure to bring Australian mRNA research and other RNA-based therapeutic modalities to the clinic.”
BioCina and its partners will also develop mRNA-based therapies to treat other types of diseases such as cystic fibrosis, heart disease, rare genetic diseases and certain cancers.
From bench to bedside, do it all in Australia
Innovate. Assess. Develop. Do it all in Australia. Contact the Australian Trade and Investment Commission (Austrade) to learn more about Australia’s biological capabilities.