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.
• 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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Validated platforms for viral and bacterial targets with turnaround tailored to sponsor timelines.
Assay development and qualification for immunogenicity, cytokines, and cellular responses.
qPCR/ddPCR for quantification; targeted NGS for variant detection and quality assurance.
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.
Neutralisation and infectivity testing under SOPs; custom assay design available.
Our facility combines deep cell line expertise with robust technical capabilities, environmental monitoring, and secure access control to protect your work at every step.
Controlled conditions, stability checks, and traceable audit trails across study phases.
Method development, validation summaries, and submission‑ready documentation.
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 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.
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.
The CAP laboratory accreditation programme ultimately recognises laboratory quality and compliance. CAP accreditation is globally recognised, and provides assurance the hVIVO laboratory services are able to be deliver to a standard.
Yes. HVIVO laboratory solutions are designed to support sponsors across program phases.
Yes. We collaborate on custom assay development, qualification, and transfer.
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