Large Molecule

Vaccine assays

Our vaccine bioanalysis services assess immune response and functional activity across development stages.

Immunogenicity Assessment (Humoral & Cellular)

    We support comprehensive immune response characterization, including

  • Binding antibody assays (e.g., antigen specific IgG/IgM/IgA)
  • Neutralizing antibody assays (live virus, or surrogate formats, as appropriate)
  • Avidity and functional antibody assessments (where relevant to mechanism)
  • Cell-mediated immunity evaluations (e.g., T cell response profiling)
  • Cytokine and immune marker profiling to support immune monitoring and correlates exploration
  • Plaque Reduction Neutralization Test (PRNT)
Clinical Trial Feasibility

Assay Development, Qualification & Validation

    Vaccine assays often evolve as clinical understanding advances. Cliantha Vaccines offers

  • Assay development and optimization (sensitivity, specificity, selectivity, robustness)
  • Fit for purpose qualification for exploratory and early phase use
  • Method validation/verification aligned to intended use and applicable guidelines
  • Matrix and interference assessments to support real world sample performance
  • Protocol-driven execution with controlled documentation and traceability

Quality & Compliance Mindset

    Quality is built into every stage of our workflow—from method design to reporting. Our teams operate using

  • Documented procedures and controlled templates
  • Protocol-driven testing and defined acceptance criteria
  • Structured data review and audit-ready documentation
  • Lifecycle support for methods as programs progress

What You Receive

    Depending on your program needs, we provide sponsor-ready outputs such as:

  • Validated/qualified assay reports and method documentation
  • Sample analysis results with clear QC summaries
  • Data tables and interpretive summaries aligned to study endpoints
  • Technical transfer/bridging documentation when required
  • Deviation and investigation documentation (where applicable) with impact assessment

Why Cliantha Vaccines

    Sponsors choose Cliantha Vaccines for:

  • Integrated vaccine testing within an end to end CRO model
  • Scientific depth across immunogenicity, potency, and biomarker endpoints
  • Scalable operations to support early studies through large clinical programs
  • Regulatory-aligned documentation and audit-ready practices
  • Responsive execution that adapts as protocols evolve

Let’s Talk About Your
Upcoming Vaccine Program

Cliantha's vaccine experience can help you implement a testing strategy that is robust, scalable, and submission supportive.