Integrated GMP Manufacturing of RNA —
From Plasmid to Patient
Aurora Biosynthetics is an advanced manufacturing provider of GMP services for teams seeking RNA-based products, including pDNA, RNA drug substance, LNP formulation, and fill/finish.
Aurora serves its customers from a single purpose-built facility in Sydney, Australia. One site, one quality system, with customer subsequent access to Australia’s 43.5% R&D Tax Incentive and CTN clinical trial pathway.
Who We Are
Scientists and industry leaders, who have delivered multiple RNA-LNP programs, have also founded Aurora Biosynthetics. The founding team brings experience spanning from concept to whiteboard design, from early process development to first-in-human and GMP clinical operations across multiple regulatory jurisdictions. Naturally a team with this record also brings experience that can accelerate customer programs – including expertise and direct experience in key workflows underlying success, such as process development or process re-engineering as needed, GMP manufacturing, and batch release for clinical applications.
Aurora’s purpose-built facility in Sydney integrates process and analytical development, GMP manufacturing, and quality control under a single site with one quality management system.
Aurora Biosynthetics operates independently, with a facility designed and developed in collaboration with the New South Wales Government, as part of a its commitment to build critical manufacturing infrastructure. The Government has retained Aurora to help foster, support, and enable a thriving localized biotech ecosystem.
Why Aurora
Aurora’s design eliminates the complexity of multi-vendor GMP manufacturing. Instead of coordinating separate providers for pDNA, RNA drug substance, LNP formulation, and fill/finish, Aurora consolidates all stages under one roof. With Aurora’s integrated single-site model, sponsors eliminate the conventional trade-offs required between speed, quality, and cost with the latter element enabled by Australia’s R&D Tax Incentive.
Aurora operates in a jurisdiction with strong intellectual property protections and full BIOSECURE Act compliance.
Our Services
Engage Aurora for individual services or the full chain of services needed for your program.
One site, one quality system, one point of accountability.
DNA Production
Manufacturing
(LNP) Formulation
This comprehensive suite of services enables Aurora to offer a streamlined, one-stop solution that reduces complexity and accelerates time-to-market for its collaborators and clients.
Partnering for Success
Aurora assigns a dedicated project team to every program, providing a single point of accountability from onboarding through batch release. Process and analytical development teams work directly alongside GMP manufacturing, stewarding your program through each stage without handoffs between separate organizations.
Regulatory strategy is embedded in every engagement. Aurora collaborates with its customers, to develop manufacturing and analytical data packages designed to support submissions across multiple regulatory jurisdictions. Analytical methods for your process are developed in parallel (not sequentially) and allow your program to attain CMC readiness faster.
What Our Partners Are Saying
“Building a sovereign RNA ecosystem isn’t just a strategic priority—it’s an opportunity to shape the future of healthcare, biotechnology, and advanced manufacturing. The NSW Government has committed over $200 million to this national endeavour, and Aurora Biosynthetics’ RNA manufacturing facility is at the heart of it. That’s why we’re backing the construction of this critical capability—because with Aurora, we’re building the foundation for Australia to not just participate in the RNA revolution, but to lead it.”
“Many biotechs are taking on the toughest challenges to create innovative and vital in vivo therapeutic solutions to people who need them most. We have clinical trials ongoing and an emerging pipeline of in vivo drugs that have spanned from our groundbreaking drug discovery methods. We are proud to be working with Aurora, who has been a trusted partner since September 2024, and has been instrumental in helping us drive our programs toward patients in need.”