360biolabs’ Infectious Diseases Centre of Excellence Accelerates Clinical Trial Success
In the race to combat infectious diseases, speed, accuracy, and adaptability are everything. That’s why 360biolabs, a BioAgilytix company, is proud to announce the expansion of our ready-to-deploy assay portfolio tailored to support respiratory virus vaccine and therapeutic clinical trials with unmatched efficiency.
Whether you’re running early-phase trials or advancing complex, multi-site programs, our off-the-shelf validated assays and integrated immunological and molecular endpoint services provide the depth and flexibility today’s vaccine development demands.
Assay Innovation Meets Infectious Disease Expertise
At the heart of this expansion is our state-of-the-art virology and infectious diseases facility in Melbourne, equipped with certified BSL-2 and BSL-2 containment laboratories. Our scientists are deeply experienced in supporting clinical trials targeting a broad spectrum of infectious agents, both endemic and emerging. 360biolabs has supported 225+ infectious diseases clinical studies from 2023 to 2025 and analysed >115,000 clinical samples during this period.
Our expanded services include validated assays for key respiratory viruses, providing advanced endpoint analysis for early-phase vaccine trials. We have introduced both live-virus assays plus pseudovirus assays where live-virus is not possible due to containment level or importation regulations.
Key Assay Platforms Now Available Off the Shelf
We’ve boosted our virology capabilities to include a wider range of fully developed and validated, ready-to-go assays for rapid study start up and accelerated timelines.
Cell Culture-Based Assays
Still a gold standard in virology, cell-based platforms like plaque assays and cytopathic effect (CPE) assays provide direct insights into viral replication.
Neutralisation Assays
Measure the functional ability of neutralising antibodies for assessment of vaccine protection or antivirals to block infection at key viral lifecycle stages.
HAI Assays
Essential for influenza clinical trials, Haemagglutination Inhibition (HAI) assays quantify functional antibodies that prevent red blood cell agglutination, a proxy for immunity.
Molecular Virology
Advanced qPCR and dPCR methods support viral detection and quantification, mutation tracking, vector titre analysis and viral shedding studies.
What’s New: Expanded Respiratory Virus Assays
To meet continued requests for clinical trial support, 360biolabs has added new off-the-shelf respiratory virus assays to its service repertoire, including neutralisation titre assessment for RSV A and B, metapneumovirus, parainfluenza, influenza, H1N1, H3N2, B and HAI assays for influenza strains:
- Plaque Reduction Neutralisation Test (PRNT) for metapneumovirus and parainfluenza
- Microneutralisation Test (MNT) for RSV subtypes A and B
- HAI and neutralisation assays for influenza
Pseudovirus Assays for High-Containment Pathogens
Pathogens, for example, influenza H5N1 and monkeypox, cannot be cultured safely in Australia due to importation restrictions and biosecurity requirements. To overcome this, we’ve developed pseudovirus -based assays that mimic whole virus infection without fully replicating. These safe, BSL-2 compliant assays offer powerful tools to measure neutralising antibodies, evaluate vaccine-induced immune responses and accelerate development of pandemic-ready vaccines.
Custom Solutions for Complex Programs
While our off-the-shelf assays offer speed and standardisation, we also specialise in custom assay development for trials with unique targets or endpoints. Our scientists blend expertise in virology, immunology, and molecular biology to deliver bespoke assay solutions tailored to your trial’s specific needs.
Integrated Immune Endpoint Support
A comprehensive picture of vaccine efficacy requires more than viral titres. We offer a full suite of humoral and cellular immune assays to support endpoint analysis across all immune response dimensions:
- Humoral assays: ELISA: absorbance-based and MSD-ECL and IgG, IgM, IgA serology
- Cellular assays: ELISpot, Immunophenotyping: standard and spectral flow, and Intracellular cytokine staining (ICS)
- PBMC services: Isolation, cryopreservation and storage
A Strategic Edge: Conducting Trials in Australia
Australia’s location in the Southern Hemisphere offers a strategic advantage for extending seasonal respiratory virus clinical trials beyond the Northern Hemisphere winter. By shifting trial activity to coincide with the Southern Hemisphere winter, sponsors can avoid seasonal delays and accelerate study completion by up to six months.
” We saved 6 months, recruitment exceeded expectations, and the study cost 40% less than running it in Europe.” — Vaccitech
Australia is a preferred destination for early-phase clinical trials due to its pragmatic regulatory environment and rapid approval process. The strong R&D tax incentives make conducting clinical trials up to 60% cheaper than in the USA, without compromising on quality. Australia is an OECD country, ensuring data generated in Australia is accepted by global regulatory agencies. A highly skilled and English-speaking workforce simplifies communication and collaboration.
At 360biolabs, we don’t just provide data, we deliver insights that drive decisions. Our expanded infectious diseases validate, and advance vaccines and therapeutics that are changing the future of global health.
Whether you’re working with a known virus or developing countermeasures against emerging threats, we’re ready to help you move forward, faster, smarter, and more confidently.
Learn how our infectious diseases expertise can accelerate your clinical trials.