Laboratory Solutions

Specialist Infectious Disease Immunology Laboratory Solutions

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hVIVO_Lab_Services_BSL_3_infectious diseases

Specialist Infectious Disease Immunology Laboratory Solutions

Providing highly specialised infectious disease and immunology laboratory services, hVIVO is an expert in immunology, molecular, and cell-based assay development, with advanced sample handling and testing using the latest platforms to support sponsor requirements from pre-clinical to Phase III.

Our Expertise

  • Immunology assay development (immunogenicity, cytokine/biomarker profiling)
  • Molecular assays (qPCR/ddPCR, NGS panels) and contamination screening
  • Cell-based assays (neutralisation, infectivity, cytotoxicity)
  • Microbiology (Operating at Containment Level 2 (CL2))
  • Advanced sample handling and chain-of-custody with secure data integrity
  • Programme support from pre-clinical through Phase III trials
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Core Services

Infectious Disease Testing

Validated platforms for viral and bacterial targets with turnaround tailored to sponsor timelines.

Immunology & Biomarkers

Assay development and qualification for immunogenicity, cytokines and cellular responses.

Molecular & Genomics

qPCR/ddPCR for quantification: targeted NGS for variant detection and quality assurance.

 

Microbiology

Rapid setup and delivery of microbiological analyses, fully aligned with ICH Good Clinical Practice (GCP). Designed for high-throughput sample processing, we provide end-to-end support for bacterial challenge studies and microbiology-based research.

Cell-Based Assays

Neutralisation and infectivity testing under SOPs; custom assay design available.

Cell Culture Lab

Our facility combines deep cell line expertise with robust technical capabilities, environmental monitoring, and secure access control to protect your work at every step.

Sample Handling Logistics

Controlled conditions, stability checks, and traceable audit trails across study phases.

Study Support (Pre‑clinical → Phase III)

Method development, validation summaries, and submission‑ready documentation.

Biospecimen & Drug Product Storage

Biobanking services for human biospecimens for research, specialising in respiratory infection samples. In addition, hVIVO provides storage solutions from ambient to ultra-low temperatures for all your sample and compound requirements.

PBMC Processing & Isolation

Local Sample Processing PBMC Processing for Robust Immunology Research  

Lab Accreditations: CAP, UKAS, GCLP, HTA

Our laboratory accreditations and quality standards, including UKAS, CAP and GCLP compliance.

Bioanalysis Services | Sample Characterisation

Bioanalysis and characterisation services supporting PK, PD and immunogenicity endpoints, run to GCLP standards.

Clinical Trial Supplies & Kit Production

Clinical trial supplies and bespoke sample collection kit production, assembled and distributed to study sites.

Human Biological Samples | Biobank & Collection

Access to well characterised human biological samples, collected and stored under HTA licence.

Laboratory Consulting | Regulatory & Scientific

Scientific consulting and regulatory support for laboratory strategy, method selection and submission readiness.

Virology Services | Advanced Viral Assays

Specialist virology capability, including viral quantification, culture and molecular detection.

From pre-clinical and translational work through to supporting large phase III studies our laboratories team are experienced from R&D through to tech transfer and operational delivery

Start ups

Early-stage start up biotechs are driving some of the most exciting innovation in therapeutics — but they also face unique barriers that slow progress, increase risk, and strain lean internal teams. Our start-up support model is built specifically to address these challenges, accelerate development, and help founders reach clinical and commercial milestones with confidence. 

Biotech

We help biotechs progress assets efficiently from early development into clinical proof by providing the scientific depth, specialist labs, and operational infrastructure needed to overcome industry‑specific challenges. 

Large Pharma

Partner with our owned clinical sites, specialist populations, Clinical Pharmacology Units, and Human Challenge Unit to deliver fast, predictable early‑phase studies. 

Featured Article

Regulatory Strategy as Competitive Advantage: From Compliance to Acceleration

For many years, regulatory affairs were viewed as a necessary hurdle in drug development. The role was to ensure compliance, prepare dossiers, and shepherd submissions through complex national and international frameworks. That perception is outdated. Today, regulatory strategy is not simply about compliance; it is a source of competitive advantage. When integrated early into drug development planning, regulatory expertise can accelerate timelines, de‑risk programmes, and even enhance the commercial value of a compound. At hVIVO, our regulatory experts have seen this transformation first‑hand. Their experience across early‑phase clinical trials, human challenge studies, and complex therapeutic areas has shown that regulatory affairs are no longer confined to the back room. They are central to shaping development pathways, influencing policy, and ensuring that innovative treatments reach patients more quickly.

Vi Stuart Regulatory Affairs Consultant.
8 min read
View

Core Services

hVIVO is led by a dynamic group of experts in their respective fields who are driving excellence throughout the organisation.

Our Accreditations

Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard; for designing, conducting, recording and reporting trials. Ensuring participant safety prevails over the interests of science and society.

 

HVIVO-ACCREDITATION-MHRA

 

Human Tissue Authority (HTA)

hVIVO is accredited by the Human Tissue Authority (HTA), meaning that we have been recognized by the HTA as compliant with standards and regulations for the ethical and legal removal, storage, and use of human tissue. A HTA license is essential, as hVIVO handles human tissue for various research purposes.

 

HVIVO-ACCREDITATION-HTA

 

Good Clinical Laboratory Practice (GCLP)

 All clinical trials comply with GCP and/or GCP for Laboratories (GCLP) guidance. Human Challenge Agent-only clinical studies that do not involve IMP also comply with GCP/GCLP. 

 

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hVIVO is a UKAS accredited Testing Laboratory No. 27882

UKAS Schedule of Accreditation

HVIVO-ACCREDITATION-HVIVO

 

FAQ

Get in touch with us

Yes. HVIVO laboratory solutions are designed to support sponsors across program phases.

Yes. We collaborate on custom assay development, qualification, and transfer.