hVIVO Laboratory Services for Human Challenge Studies
25+
years experience in challenge agent development and clinical virology
GLP/GCP‑aligned labs with validated assays across respiratory & infectious diseases
Rapid, high‑quality data turnaround, enabling faster decision‑making
Industry‑leading immunology & virology expertise supporting Phase I-III trials
GCLP and ISO 17025-2017 certified
Start‑ups & Early‑stage Biotechs
Access high‑quality immunology & virology capabilities, accelerate decision‑making.
Emerging & Mid‑size Biotechs
Large Pharma
The Service
End‑to‑end scientific and analytical support for human challenge trials, including challenge agent characterisation, sample testing, exploratory biomarkers, virology, immunology, molecular analysis, and bioanalysis.
The Process
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Assay Design & Feasibility – Identify the most appropriate assays and biomarkers for your model.
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Validation & Optimisation – Validate or transfer assays to meet regulatory and model‑specific requirements.
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Sample Collection & Processing – Integrated clinic‑to‑lab workflows ensure high integrity.
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Testing & Data Generation – Virology, immunology, and molecular assays conducted under GLP/GCP alignment.
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Data Reporting & Interpretation – High‑resolution datasets with expert interpretation.
hVIVO Capabilities
Virology
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qPCR
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Viral load
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Viral kinetics
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Infectivity assays
- Viral culture
Immunology
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ELISA
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ELISpot
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Flow cytometry
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Serology
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Cytokine multiplex
Molecular
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PCR panels
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Sequencing
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Gene expression analysis
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NGS and bioinformatics
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Rapid PCR qualification of respiratory infections, through single and multiple target quantification at scale using RT-qPCR and ddPCR platforms underpinned by Hamilton automated platforms
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Genotyping and variant analysis utilising NGS in accordance with FDA guidance.
Bioanalytical
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PK/PD assays
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Host immune response markers
Why hVIVO?
- Purpose‑built labs for controlled infection models with disease‑specific assays
- Integrated clinical and lab workflows ensure speed and accuracy
- Experts in respiratory and infectious diseases across influenza, RSV, HRV, hMPV, SARS‑CoV‑2, malaria, and more
- Regulatory‑aligned workflows designed for IND/CTA support
- Large BSL-2 and BSL-3 facilities
Related Resources
From RSV to hMPV: Building the Next Generation of Respiratory Challenge Models
Controlled Human Infection Model's (CHIM) in your backpack: how Human Challenge Trials support regulatory approval of travel vaccines
Unravelling the hMPV Surge: From Media Attention to Vaccine Development
Why are Biotech’s & Pharma Using Human Challenge Studies for Drug Development?
Tripledemic Takedown: How Human Challenge Trials are Ideal to Expedite Multivalent Vaccine Development
Empowering Next‑Gen Infectious Disease & Vaccine Development
Human Challenge Studies: Their Conduct and Safety Aspects
Human Challenge Trials as a tool in raising funding
UK Life Sciences Sector Plan 2025: What it Means for the Future of Clinical Research
The UK Regulatory Competitiveness in an ever changing world
Virology, immunology, molecular, and bioanalytical assays optimised for challenge models.
Bring your challenge model to life with expert scientific support