Case Studies

The Challenge

Hendra virus is a deadly zoonotic pathogen transmitted from flying foxes to horses and occasionally to humans in Australia. Nipah virus, a closely related paramyxovirus, causes periodic outbreaks across South and Southeast Asia with case fatality rates exceeding 70%. No approved antiviral treatments existed for either virus.

NBF's Role

Originally developed by scientists at the US National Institutes of Health (NIH), the m102.4 monoclonal antibody was identified as a potent neutraliser of both Hendra and Nipah viruses. NBF was contracted to manufacture clinical-grade material for ongoing stockpiling and clinical evaluation.

• Upstream process development and manufacturing of m102.4 at clinical scale
• Downstream purification and formulation for clinical-grade drug substance
• Bioanalytics package for release testing and stability
• Continuous production campaigns for Queensland Health's emergency stockpile

Outcomes

The NBF team successfully completed a first-in-human Phase I clinical trial for m102.4, with results published in The Lancet Infectious Diseases. Beyond clinical trials, the antibody has been used under special access protocols to treat individuals following high-risk Hendra virus exposures in Australia and has been provided under humanitarian need into India during ongoing Nipah virus outbreaks.

View publication in The Lancet Infectious Diseases

The Challenge

In January 2020, the emergence of SARS-CoV-2 demanded an unprecedented global vaccine response. UQ's Molecular Clamp, a recombinant protein-based subunit platform (~600 kDa spike trimer), had been developed as a rapid-response vaccine technology. What was needed was the manufacturing expertise to take it from laboratory concept to clinical-grade material in record time.

NBF's Role

Multiple TIA (Therapeutic Innovation Australia) nodes prioritised the project during the initial lockdown. NBF led the accelerated development effort:

• Accelerated process development with novel capture affinity resin
• Established a Phase I-enabling analytical package
• Supported preclinical studies with 20L transient expression batches
• Concurrent cell line development, stable pool clinical drug substance at 50L scale
• First patient injected within 5.5 months of project initiation

Outcomes

The first clinical trial dosed its first participant within 5.5 months, a remarkable timeline for a novel biologic. A second clinical trial followed on a redesigned clamp antigen. The de-risking achieved through two NBF-enabled clinical trials was pivotal to the platform's commercial value.

UQ's Molecular Clamp technology was subsequently commercialised through spinout company Vicebio, which was acquired by Sanofi for over $1.15 billion USD, validating both the platform's potential and the critical role of Australian manufacturing infrastructure in creating globally significant biotherapeutic assets.

View clinical trial publication in Journal of Infectious Diseases View publication in eBioMedicine Read the full Vicebio story

The Challenge

Ovarian cancer remains one of the most difficult cancers to detect and treat. CDCP1 (CUB domain-containing protein 1) was identified as a promising molecular target overexpressed on ovarian cancer cells. The goal was to develop an anti-CDCP1 antibody that could serve dual functions, as a diagnostic imaging agent via radiolabel conjugation and as a potential therapeutic.

NBF's Role

NBF provided the complete end-to-end biologics development pathway, covering every step from early-stage antibody evaluation through clinical manufacturing:

• Evaluated 5 candidate antibodies for manufacturability, accelerated stability, SPR binding, and in vitro/in vivo performance
• Isolated a stable clone of the lead candidate achieving approximately 3.5 g/L titre
• Developed the full bioprocess and analytics package
• Managed technology transfer from UQ NBF to CSIRO for DFO conjugation development
• Completed clinical drug product batch manufacturing

Outcomes

The 10D7 project exemplifies a complete Australian biologics success story. Every step, from initial antibody discovery through to first-in-human trials: was conducted domestically, apart from a single toxicology study overseas. The clinical trial is now underway, evaluating the antibody for imaging of ovarian cancer patients.

National research infrastructure including NBF, the National Imaging Facility, and Therapeutic Innovation Australia were essential enablers, demonstrating how Australian capabilities can support seamless translational pathways without the need for offshore facilities.

Read the full ovarian cancer story

The Challenge

Malaria caused more than 280 million infections across over 80 countries and more than 600,000 deaths in 2024. Accurate diagnosis is central to elimination, yet the most dangerous parasite, Plasmodium falciparum, has evolved to evade many of the rapid diagnostic tests used across Sub-Saharan Africa, while Plasmodium vivax often causes "silent", asymptomatic infections that create hidden reservoirs of disease. Developing more sensitive tests depends on a reliable supply of high-quality diagnostic proteins, which are often out of reach for researchers and small companies in resource-limited settings.

NBF's Role

The work began at UQ's Protein Expression Facility (PEF), which joined forces with NBF in 2026 and now operates under the NBF banner. Since 2021 the team has supplied diagnostic target proteins for all five species of the Plasmodium parasite, with particular focus on P. falciparum and P. vivax:

• Produces recombinant diagnostic antigens covering all five Plasmodium species
• Runs dedicated quality-control processes for malaria antigens
• Supplies proteins worldwide for diagnostic test development and treatment research
• Offers custom protein development tailored to each program
• Provides reagents at affordable cost to startups, small companies and researchers with limited budgets

Outcomes

The facility's proteins have helped global-health partners including PATH, the Burnet Institute and WEHI design more sensitive diagnostic tests capable of detecting parasites that evade current rapid tests, supporting the surveillance and mass test-and-treat programs essential to malaria elimination. By keeping reagents affordable, the work extends equitable access to critical diagnostic tools well beyond well-resourced laboratories.

"We are supplying orders worldwide," said Dr Christian Fercher, who led the work at PEF and is now part of the NBF team. "These clients are often startups or small companies that don't have big budgets, and we are able to provide the proteins at a reasonable price."

Read the full malaria proteins story