Specialty laboratories provide advanced capabilities beyond routine diagnostics, positioning them at the forefront of infectious disease research and development.
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The strength of these laboratories lies in their potential to provide a multifaceted approach, integrating molecular, virology, and immunology techniques to deliver comprehensive insights for antiviral drug discovery, vaccine development, and translational research.
Cell culture is a key foundation for drug screening, viral propagation, and physiologically relevant modelling, complementing immunological and genomic analyses. This ensures high specificity, sensitivity, and reproducibility, allowing their users to perform accurate immune profiling, pathogen detection, and functional characterization.
Benefits of a multi-faceted approach
Single-modality testing is typically unable to capture the complexity of infectious diseases due to pathogens’ capacity for rapid evolution. Specialty labs combine viral infectivity assays, genomic analysis, immune response profiling, and cell culture systems to:
- Enhance diagnostic yield and reduce turnaround times
- Support regulatory-compliant workflows for clinical trials
- Facilitate real-time surveillance and outbreak response
- Power innovation in therapeutic and vaccine development via the development of physiologically relevant models
Core pillars and techniques
Molecular and genomics
This suite of tools is ideally suited to biomarker discovery, vaccine research, diagnostics development, and Phase I–III clinical trials. Techniques include:
- qPCR & ddPCR for the quantification of gene expression and viral load
- Next-Generation Sequencing (NGS) for whole genome sequencing, microbiome analysis, and variant calling
- Multi-pathogen screening via advanced platforms such as GenMark® ePlex®, and BioFire®
- Biomarker profiling for translational research and diagnostics
Virology
This suite of tools is suitable for research on respiratory pathogens, antiviral drug development, and emerging infectious disease programs.
Techniques include:
- Viral quantification via TCID50, Plaque Assays, and Focus Forming Assays (FFA)
- Antiviral screening via drug potency assays (IC50/IC90)
- Antibody functionality via neutralization and ligand binding assays
- Resistance monitoring via NGS
Immunology
The suite of tools is ideally suited to vaccine development, infectious disease research, immunogenicity studies, and cardiometabolic biomarker analysis. Techniques include:
- Protein and antibody quantification via ELISA
- Antigen-specific T cell analysis via ELISpot
- Immune signaling via Multiplex cytokine profiling
- Functional antibody activity via neutralization assays
- PBMC isolation and immune repertoire sequencing
Cell culture
These types of tools are suitable for a wide range of applications, including viral infectivity and neutralization assays, vaccine candidate evaluation aligned with relevant regulatory guidelines, and mechanistic studies of host-pathogen interactions; as well as antiviral drug screening and cytotoxicity testing, and neutralizing antibody assessments and biological potency measurements.
Techniques include:
- Establishing appropriate cell lines like MDCK, HEK293, CHO, and Vero. These cell lines are cultured under strict conditions and employed in critical steps such as cell-based assays and respiratory virus propagation.
- Immunogenicity and host-pathogen interaction studies via primary human PBMCs
- Two-dimensional and three-dimensional culture models for physiologically relevant assays
- Lab-scale bioreactors for scale-up and cell culture, as appropriate
Advantages of working with a multifaceted specialty laboratory
There are several tangible benefits to working with a specialty laboratory that offers multifaceted capabilities.
For example, the laboratory can provide comprehensive insights across pathogen detection, infectivity, and immune response, as well as help to expedite drug and vaccine development.
Defensible, high-quality data is available for regulatory submissions, with global standardization made possible via powerful automation and LIMS integration.
Specialty laboratories like hVIVO will continue to be at the forefront of innovation, integrating these diverse and highly beneficial technologies into validated workflow designs to better ensure resilience against evolving pathogens.
Acknowledgments
Produced from materials originally authored by hVIVO.
About hVIVO
hVIVO is a full-service early phase CRO offering end-to-end drug development services from preclinical consultancy through to Phase III clinical trials, including world-leading end-to-end human challenge trials services. With decades of experience in rapidly delivering data for our global client base, our team brings together strategic insight and operational expertise to deliver a variety of clinical study types across multiple locations.
To support rapid study start-up and reliable delivery, our dedicated recruitment teams in Germany and the UK provide direct access to both healthy volunteers and patient populations. This is complemented by our integrated drug development consultancy, as well as our infectious disease and immunology laboratories and biobanking services.
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