What 360biolabs does

360biolabs is an Australian contract research organization (CRO) founded in 2015 in Melbourne that provides integrated bioanalytical laboratory services for early-phase clinical trials. Its service portfolio spans pharmacokinetics (via LC-MS/MS and immunoassays), pharmacodynamics (via flow cytometry, molecular assays, and soluble biomarkers), immunogenicity (screening, confirmatory, titer, and neutralizing antibody assays), biomarker analysis (500+ biomarkers across MSD, Simoa, Luminex, flow cytometry, qPCR/dPCR, and ELISpot platforms), vaccines and infectious diseases (BSL-2/BSL-3 virology including PRNT, MNT, FRNT, and pseudovirus assays), and central laboratory services (kit production, lab manuals, LIMS-controlled sample tracking, PBMC isolation, and 24/7 biobanking). The business operates from purpose-built facilities in Melbourne's Alfred Research Alliance precinct (approximately 3,000 sq m, including BSL-3 labs and 10+ LC-MS/MS instruments) and Brisbane's Translational Research Institute, with BSL-3 capability also co-located at the Burnet Institute. Revenue is generated through fee-for-service contracts on a per-project, per-study, or per-sample basis, with pricing negotiated by assay complexity, throughput, and regulatory requirements; ancillary managed-services revenue arises from central lab support. The customer base comprises pharmaceutical and biotechnology companies (primarily enterprise sponsors developing small molecules, biologics, vaccines, and cell/gene therapies), contract research organizations acting as indirect channels, and academic medical centers. International sponsors are a primary commercial focus, with go-to-market activity emphasizing the 'Australian Advantage': 4-6 week Phase 1 ethics approvals (no IND required), a 43.5% R&D tax incentive, up to 60% cost savings versus US trials, and Southern Hemisphere seasonal alignment for respiratory virus studies that can shorten timelines by up to 6 months.

The company was acquired in 2021 by BioAgilytix, a US-headquartered global bioanalytical services provider, with the combined network now operating six laboratories across Australia, the United States (Durham, Boston, San Diego), Germany (Hamburg), and partner laboratories in China. BioAgilytix leadership (CEO Davide Molho, previously COO of Charles River Laboratories and CEO of Viroclinics Biosciences) sits above 360biolabs' retained founding executive team: President Alistair Draffan (PhD, organic chemistry; ex-Director of Drug Discovery at Biota Pharmaceuticals), Executive Vice President of Scientific Operations Melinda Pryor (PhD, virology), and Executive Vice President of Commercial Angela Luttick. The integration provides 360biolabs' Phase 1 customers with a seamless pathway into BioAgilytix's US and European laboratories for Phase 2+ sample analysis without re-procurement, materially expanding the addressable market for both entities.

Operationally, 360biolabs is distinguished as the first Australian laboratory to develop and validate SARS-CoV-2 microneutralization assays in 2020 and has since supported 25+ SARS-CoV-2 clinical studies with over 60,000 samples received from international programs, 90+ vaccine clinical trials cumulatively (80% growth in non-COVID trials during 2020-2025), and 225+ infectious disease studies with 115,000+ samples analyzed during 2023-2025. Named customers include Novavax (Phase 3 COVID-19 variant trial with distributed PBMC processing across two Australian sites), Vaccitech (vaccine Phase 1 with reported 6-month timeline acceleration and 40% cost savings versus Europe), Diagenta (central lab start-up services), and Swinburne University (SARS-CoV-2 viricidal surface testing). NATA-accredited for ISO/IEC 17025, GLP, and GCLP, the company is positioned as the most comprehensive Australian bioanalytical CRO, though standalone revenue remains undisclosed, and the operating model is now tightly linked to parent BioAgilytix's global commercial pipeline.

Name

360biolabs

Legal name

360biolabs Pty Ltd

Website

https://360biolabs.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

1–10 employees

Short description

360biolabs is an Australian bioanalytical contract research organization (CRO) and subsidiary of BioAgilytix providing pharmacokinetic, pharmacodynamic, immunogenicity, biomarker, vaccine/infectious disease, and central laboratory services for early-phase clinical trials of pharmaceutical and biotechnology sponsors globally.

Ownership category

akta.pro rank

Product category

Bioanalytical Contract Research Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Medical Laboratories (621511), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)

akta.pro primary industry

Bioanalytical & Biomarker CROs (PK/PD/Immunogenicity) (HLAGAAAD)

akta.pro secondary industries

Clinical CROs (Phase I–IV) (HLAGAAAA), Central Laboratory & Clinical Trial Testing CROs (HLAGAAAE)

Keywords

• Bioanalytical laboratory services
• Clinical trial sample testing
• Pharmacokinetic assay services
• Immunogenicity testing services
• Contract research organization

Headquarters

HQ city

Melbourne

HQ country

Australia

HQ region

Oceania

Offices8 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Contract Research Services: 360biolabs operates as a contract research organization providing bioanalytical laboratory services for clinical trials. Revenue is generated through fee-for-service contracts for assay development, validation, and sample testing across pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and infectious disease services. Services are billed per project, study, or sample basis with pricing based on assay complexity, throughput, and regulatory requirements.
2. Central Laboratory Services: Additional revenue streams include central laboratory services such as kit production, laboratory manual development, sample management, biobanking, and logistics coordination. These operational support services complement core bioanalytical testing.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels9 records

Core offering

360biolabs is Australia's most comprehensive bioanalytical contract research organization (CRO) providing pharmacokinetic (PK), pharmacodynamic (PD), immunogenicity, biomarker, vaccine and infectious disease, and central laboratory services for early-phase clinical trials. It delivers assay development, validation, and sample testing across LC-MS/MS, flow cytometry, PCR, immunoassay, and virology platforms for pharmaceutical and biotechnology sponsors.

Product overview

360biolabs is Australia's most comprehensive bioanalytical laboratory offering a unified suite of pharmacokinetic and pharmacodynamic assay services for early-phase clinical studies. The core portfolio consists of Pharmacokinetics, Pharmacodynamics, Immunogenicity, Biomarkers, Vaccines & Infectious Diseases, and Central Lab Services. Pharmacokinetics encompasses LC-MS/MS and immunoassay/ligand-binding assay capabilities. Pharmacodynamics includes flow cytometry and molecular assays. Immunogenicity covers anti-drug antibody (ADA) and neutralizing antibody (NAb) testing. The service offering integrates Central Lab Services (Kit Production, Lab Manuals, PBMC Isolation, biobanking), Biomarkers (using MSD, Simoa, Luminex platforms), Vaccines & Infectious Diseases (virology assays, neutralization tests), and Flow Cytometry (high-parameter single-cell analysis). Molecular Assays provide qPCR, dPCR, and gene expression analysis. LC-MS/MS supports both small and large molecule bioanalysis. All services operate under GLP, GCP, and ISO/IEC 17025 quality standards with global support from BioAgilytix laboratories for Phase 2+ studies.

Differentiator

Problem solved

Functional benefit

Products and services

• Pharmacokinetics (PK) Comprehensive pharmacokinetic assay development, validation, and sample testing services for various drug modalities and sample types, utilizing LC-MS/MS and immunoassay platforms to support clinical pharmacology studies for pharmaceutical and biotechnology sponsors.
• Pharmacodynamics (PD) Pharmacodynamic biomarker assessments measuring how drugs affect biological systems, including soluble biomarkers, molecular events, and cellular phenotyping via flow cytometry. Used by pharma and biotech sponsors to demonstrate proof of mechanism and dose response in early-phase clinical trials.
• Immunogenicity Assessment of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) for biotherapeutics using multi-tiered screening, confirmatory, titer, and characterization assays compliant with FDA/EMA regulatory standards. Targeted at sponsors developing biologics and biotherapeutics.
• Biomarkers Biomarker analysis for therapeutic efficacy, safety, and mechanism-of-action assessment using LC-MS/MS, ligand-binding assays (MSD, Simoa, Luminex), and flow cytometry across multiple matrices. Supports therapeutic development programs across a wide range of disease states.
• Vaccines and Infectious Diseases Comprehensive virology and infectious disease services including culture-based assays (TCID50, Plaque Assay), neutralization tests (PRNT, MNT, FRNT), ELISpot, HAI assays, and molecular diagnostics for vaccine development and pathogen research. Used by vaccine developers and infectious disease researchers.
• Central Lab Services Integrated central laboratory services encompassing protocol-specific kit production, laboratory manuals, LIMS-controlled sample tracking, PBMC isolation, and 24/7 monitored biobanking for multi-site clinical trials. Provides end-to-end operational support for clinical study sponsors.
• LC-MS/MS Bioanalysis Liquid chromatography-mass spectrometry services for separation, identification, and quantification of small and large molecules, metabolites, peptides, proteins, ADCs, oligonucleotides, siRNA, and lipid nanoparticles for clinical and preclinical drug development.
• Flow Cytometry High-parameter single-cell analysis using Fortessa and Canto II flow cytometers for receptor occupancy, biomarker expression, immunophenotyping, cell enumeration, cytokine analysis, and minimal residual disease detection in clinical trial samples.
• Molecular Assays Real-time PCR, quantitative PCR (qPCR), and digital PCR (dPCR) services for pharmacokinetic studies of RNA-based therapeutics, cell and gene therapy solutions, gene expression analysis, viral shedding, biodistribution studies, and pathogen detection.
• Ligand-binding Assays / Immunoassays Custom immunoassay development and validation across various methodologies including MSD-ECL, Simoa, and Luminex platforms to support clinical therapeutic programs for large molecules, advanced therapies, and vaccines.
• PBMC Isolation

Quantifiable outcome

• 60% cost savings vs US trials
• +6 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Partnerships

One partnership is on record.

• BioAgilytixcoreStrategic or Co-development Partner · 1 January 2021360biolabs was acquired by BioAgilytix in 2021, creating a global bioanalytical network with laboratories in Australia, USA, and Europe. This partnership enables seamless transition of assays from Phase 1 in Australia to Phase 2+ in international locations. The acquisition expanded 360biolabs' service offering and provided access to global client base and additional technical capabilities.

Scale indicators14 records

Recent moves10 records

Expansion highlights7 records

Direct peers

• Celerion: US-based clinical pharmacology CRO specializing in early-phase clinical pharmacology and bioanalytical services for pharma and biotech. Directly comparable to 360biolabs in early-phase PK/PD/biomarker positioning, with similar global sponsor customer base.
• BioAgilytix: Parent network of 360biolabs and the company's primary peer in head-to-head bioanalytical services. Operates large-molecule bioanalysis, immunogenicity, biomarkers, and cell/gene therapy assays across US and EU hubs, providing the exact same service catalog 360biolabs offers in Australia.
• Eurofins Bioanalytical Services: Global bioanalytical CRO and part of the broader Eurofins lab network. Offers small/large molecule bioanalysis, immunogenicity, and biomarker services for pharma sponsors — a direct functional competitor for bioanalytical contracts that 360biolabs targets.
• Frontage Laboratories: US-headquartered CRO with bioanalytical, biomarker, and CMC services. Comparable in offering bioanalytical support to pharma/biotech sponsors and competes for similar Phase 1 immunogenicity and PK assay mandates.
• Inotiv (Absorption Systems): Preclinical and bioanalytical CRO with particular depth in LC-MS/MS small/large molecule bioanalysis and PK/PD services. Directly comparable scale and therapeutic-area focus to 360biolabs.
• Worldwide Clinical Trials: Mid-sized global CRO with strong bioanalytical and early-phase clinical pharmacology offerings, comparable in serving biotech and pharma sponsors across Phase 1-2 mandates.

Broad incumbents

• Charles River Laboratories: Large global CRO/CDMO with end-to-end drug development services. BioAgilytix CEO Davide Molho previously served as President and COO at Charles River, highlighting the close competitive and talent overlap with 360biolabs' parent in early-phase bioanalysis.
• IQVIA: World's largest CRO with full Phase 1-4 capabilities including central labs and bioanalytical services. Represents the largest incumbent competitor 360biolabs could face on multi-region Phase 2+ expansions.
• Labcorp Drug Development (Covance): Major global CRO with central laboratory services and early-phase clinical pharmacology capabilities. Competes for full-service clinical trial work that 360biolabs hands off from Phase 1 to Phase 2+.
• WuXi AppTec: China-based global CRO/CDMO with bioanalytical services and partner-lab footprint referenced in 360biolabs' Beijing operations. Represents a broader global incumbent in CRO/CDMO space that competes for Asia-Pacific sponsors.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInau.linkedin.com/company/360biolabs

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about 360biolabs