What is the significance of the first end-to-end mRNA process contract development and manufacturing organization (CDMO) establishment in Australia?

The establishment of the first end-to-end mRNA process Contract Development and Manufacturing Organization (CDMO) in Australia is a significant step towards building critical sovereign capability for vaccine development and production in the region. This achievement will enable Australia to produce its own mRNA vaccines and therapeutics, translating discoveries from Australia’s universities, research institutes, and start-up biotechs to deliver benefits to patients in the region.

Since this is BioCina’s first GMP facility for mRNA in Australia, it is a major milestone in strengthening Australia’s capacity to respond to future pandemics. We hope this facility can respond to supply chain vulnerabilities and secure domestic vaccine production in case of urgent needs.

This collaboration also aligns with Australia's Sovereign Manufacturing Capability Plan (SMCP), which outlines the government's goal of strengthening the country's position as a major player in the global biotech industry. By establishing an end-to-end mRNA CDMO in Australia, we are building a long-term sovereign capacity for vaccine and therapeutic development and production in the region, ensuring that we are better equipped to respond to the future health needs of the Australia population.

We are proud to be a part of establishing this important facility and look forward to working with BioCina to deliver high-quality vaccines and therapeutics.

How will the collaboration between Cytiva, the University of Adelaide, and BioCina address the lack of domestic manufacturing capacity for mRNA vaccines and therapies within the country?

The collaboration between Cytiva, the University of Adelaide, and BioCina aims to address the current lack of domestic manufacturing capacity for mRNA vaccines and therapies within Australia, by establishing core competencies in the research and development of mRNA vaccines.

This will help to translate ideas towards commercial therapeutics and expand BioCina's facility in Adelaide to support GMP manufacturing processes from in vitro transcription (IVT) to encapsulated mRNA. Additionally, this collaboration will position BioCina as Australia's first CDMO that can support the manufacturing processes for pDNA, mRNA, encapsulations, and formulation.

Apart from the initial grant from the Federal Government, BioCina has also received additional Medical Research Future Fund (MRFF) grants scheme, as well as the commitment of $5M from the South Australian Government. BioCina is well-positioned to undertake the design and manufacturing of lipid nanoparticles (LMP) that help deliver mRNA into cells with researchers at the University of Adelaide. Based on such support, the collaboration between Cytiva, the University of Adelaide, and BioCina will boost domestic manufacturing capacity for mRNA vaccines and therapies and help ensure that Australia is more self-sufficient in the production of these critical medical supplies.

Could you explain the role of the Australian government in investing in the country's biotech sector, particularly in mRNA products?

The Australian Government has identified mRNA as a key value driver for local manufacturing and sovereign capabilities during the COVID-19 pandemic. In recent years, several global pharmaceutical companies have shown interest in establishing local mRNA manufacturing hubs.

With regards to investment, the Australian Government has set up various mechanisms within the ecosystem to allow for programs, such as the one with Cytiva, University of Adelaide and BioCina, to be established. These collaboration grants specifically encourage academic and industrial entities to partner and establish capabilities locally that drive value for Australians long term.

How will the facility integrate the manufacturing processes from discovery and process development to clinical and commercial production?

The BioCina facility will integrate Cytiva’s latest technologies that provide a scalable approach that will ensure consistency across all process phases, from development to production. The facility will employ the latest generation of technologies and manufacturing platforms that enable efficient and cost-effective production of mRNA vaccines and therapeutics while adhering to the highest quality and safety standards.

Cytiva will work in collaboration with the R&D team and the manufacturing team, as well as support the ongoing training and development of the BioCina team. Ultimately, the goal is to support BioCina to provide a seamless transition from a customer’s initial discovery to commercialization, while maintaining quality, safety, and regulatory compliance at every stage of the process.

What is Cytiva's mRNA FlexFactory solution, and how does it support platform scalability, rapid deployment, and maximized efficiency?

Cytiva's mRNA FlexFactory solution is a modular and flexible single-use platform designed for the scalable and rapid production of mRNA-based therapeutics. This solution utilizes Cytiva's extensive expertise in bioprocessing technologies to enable the efficient and cost-effective production of high-quality mRNA products.

The mRNA FlexFactory solution is based on a modular design that allows for easy customization and scaling to meet the specific needs of each mRNA therapy or vaccine. The platform includes all the necessary components for mRNA production, including in vitro transcription (IVT), downstream processing and encapsulation equipment, as well as quality control and validation systems. One of the key advantages of the mRNA FlexFactory solution is its ability to support rapid deployment. The modular design allows for the platform to be quickly assembled and configured, with minimal infrastructure requirements. This makes it possible for clients to get up and running quickly, enabling them to take advantage of new market opportunities as they arise.

Another advantage of the mRNA FlexFactory solution is its ability to maximize efficiency. Cytiva's platform is designed to minimize downtime and reduce the risk of errors, while also improving product quality and yield. The platform incorporates advanced analytics and process control systems to monitor and optimize the production process, ensuring that the highest possible efficiency is achieved.

Could you elaborate on the potential of this new mRNA facility in meeting the Australian market demands and empowering the biotech ecosystem by supporting local research and development and providing a reliable supply chain?

The potential of this new mRNA facility is immense in meeting the Australian market demands and empowering the biotech ecosystem. First of all, with this new facility, BioCina will be able to strengthen the local supply chain, and we would see a decrease in the need to use overseas CDMO’s to manufacture mRNA products, resulting in time and cost savings for the country.

Moreover, this facility is part of the growth and development of the local biotech research sector. With the facility in place, local researchers will have access to the latest technologies and resources to conduct their research and develop innovative therapeutic solutions that can benefit Australian patients.

How will the establishment of the first CDMO with a complete manufacturing process for pDNA, mRNA, encapsulations, and formulations in Australia benefit the customers and ultimately the patients?

Australian and International clients will have access to a wider range of services from a single entity. They will no longer need to outsource manufacturing processes to different CDMOs in various locations outside of Australia, which can be time-consuming and expensive. Consolidating all these services in one facility can simplify the process and reduce costs for the customers. It will also reduce shipping times and costs, which is especially important for time-sensitive and temperature-sensitive products such as mRNA vaccines and therapies. This can also ensure a more reliable supply chain, which can increase patient access to life-saving therapies.

Additionally, by having a complete manufacturing process for pDNA, mRNA, encapsulations, and formulations, BioCina can provide a more seamless and integrated service. This may result in faster turnaround times, fewer errors, and improved quality control, which can ultimately benefit patients by providing the right therapeutics quickly and safely.

How does this collaboration between Cytiva, the University of Adelaide, and BioCina contribute to enhancing the country's pandemic preparedness?

The COVID-19 pandemic has highlighted the importance of having a resilient and agile healthcare system and establishing local mRNA manufacturing capability to allow us to rapidly respond to future pandemics or emerging infectious diseases. This collaboration will create a platform for not only the production of mRNA vaccines but also for other applications in disease prevention and treatment. We are committed to leveraging our expertise in bioprocessing to support Australia's healthcare sector and meet the current and future needs of the country.

Could you share any challenges faced during the establishment of this facility and how they were overcome?

This facility is still being put together, but so far, the relationship and the urgency all parties have demonstrated have been wonderful.