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Virus & Bacteria Production & Characterisation for Human Challenge Trials

GMP virus manufacturing and scientific characterisation to develop safe, infectious challenge agents for high‑fidelity human challenge trials

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GMP-compliant

viral manufacturing processes developed in-house.

Strain selection

informed by clinical sample triage, infectivity, genomic quality, and absence of adventitious agents.

Characterisation studies

show measurable, reproducible infection and symptomatic disease in volunteers and determine the appropriate concentration of the challenge agent to use in subsequent IMP efficacy studies.

Multiple strains

Used across multiple strains of RSV, influenza, SARS‑CoV‑2, hMPV, HRV and more.

Tailored customisation

of challenge agents.

The Service: Virus & Bacteria Production & Characterisation for Human Challenge Trials

Comprehensive strain selection to meet custom needs followed by challenge agent (virus or bacteria) production and characterisation including GMP manufacturing, release testing, sequencing, infectivity analysis, and human model validation.

How it Works:

Sample acquisition & triage.
Virus isolation & selection.
GMP manufacturing.
Adventitious agent and release testing for clinical use.
Clinical characterisation study.
Release for IMP efficacy testing human challenge trials.

GMP manufacturing
Cell culture laboratory
Virus isolation platforms
Sequencing & phenotyping
Safety & quality screening
Clinical characterisation expertise

World leader

World leader in development and conduct of human challenge models

End‑to‑end capability

Seamlessly integrated expertise across production, testing, and delivery of challenge agents.

Proven model

Proven success in RSV‑B, hMPV, Influenza, Malaria, COVID-19 studies

FAQ

How do you ensure that challenge agents are safe for use in human studies?

We conduct a comprehensive safety and quality screening throughout the challenge agent production process, ending in extensive testing of the GMP produced challenge agent. Testing includes genomic sequencing and variant analysis by NGS, , adventitious agent testing, and assessment of infectivity and pathogenicity. Only strains that meet strict acceptance criteria will be released for clinical characterisation. Careful clinical characterisation of the GMP challenge agent stock provides the clinical data to demonstrate the agent is safe for wider use as well as providing the disease characteristics data required to design subsequent efficacy testing challenge studies.

How do you determine whether a virus is suitable for a human challenge model?

Safety is the first consideration. Only pathogens in which a healthy adult can reasonably be expected to fully recover from without intervention or pathogens with proven effective treatments can be considered for challenge studies. Strain suitability is evaluated based on infectivity, replication kinetics, genomic stability, and the ability to induce a measurable symptomatic disease without any safety concerns.

How do you determine if the challenge agent meets my needs?

At the beginning of the process of making a bespoke challenge agent to meet a specific customer need, numerous isolates are screened and characterised by sequence and or phenotypic analysis to determine which fit the specific customer’s requirements. Selected strains are closely monitored throughout the production and characterisation processes to ensure that they have maintained the required properties.

Virus & Bacteria Production & Characterisation for Human Challenge Trials

Our end‑to‑end approach ensures safety, reproducibility, and scientific integrity.

GMP-compliant

Strain selection

Characterisation studies

Multiple strains

Tailored customisation

The Service: Virus & Bacteria Production & Characterisation for Human Challenge Trials

How it Works:

hVIVO Capabilities:

Why consider hVIVO for Virus & Bacteria Production & Characterisation for Human Challenge Trials

World leader

End‑to‑end capability

Proven model

Related Resources

Real‑World RSV Maternal Vaccine Data Marks a Turning Point for Infant Protection

A Landmark Moment for Pertussis Vaccine Development — and for the Future of Bacterial Challenge Models

Fast‑Tracking First‑in‑Human: Five Lessons Startups Can’t Afford to Miss

The Early‑Phase Anchor: Why Medical Monitoring Matters Long Before the First Dose

Paper: Mucosal and systemic immune correlates of viral control after SARS-CoV-2 infection challenge in seronegative adults

From RSV to hMPV: Building the Next Generation of Respiratory Challenge Models

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

FAQ

Bring your challenge model to life with expert scientific support

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