Our Capibilities

Pharmacokinetics by immunoassays

Project Management

  • At Cliantha Research, our dedicated Project Managers act as your central point of coordination throughout the study lifecycle. Each Project Manager brings strong scientific expertise and extensive industry experience, ensuring that project goals including timelines, deliverables, and budgets are consistently achieved. They stay closely involved in data interpretation, provide timely study updates, and offer strategic recommendations, enabling seamless project execution and well‑informed decision‑making.

Method Development

  • With deep experience in regulated large‑molecule bioanalysis, Cliantha Research specializes in the design, development, and optimization of robust immunoassay‑based bioanalytical methods. We collaborate with sponsors to select and customize assay formats based on scientific requirements, ensuring a smooth progression into method validation.

Method Validation

  • Our method development laboratory teams work in close partnership to facilitate a streamlined transition from development to validation. Prior to formal validation, each method undergoes comprehensive pre‑validation assessments to confirm ruggedness, reproducibility, and regulatory alignment. We conduct in‑house cut‑point statistical analysis, prepare essential reagents, and follow current industry and regulatory guidance to ensure your methods meet stringent scientific and compliance standards.

Sample Analysis

  • Cliantha’s large molecule bioanalysis laboratory is equipped with advanced immunoassay platforms, including MSD, ELISA, Fluorescence/Chemiluminescence (FL/CL) and flow cytometry platforms. Our team is capable of supporting studies with demanding turnaround times while maintaining the highest level of data quality and scientific integrity.

Sample Management

  • Our sample management team has extensive experience handling large sample volumes under accelerated timelines. Every sample is processed with meticulous care beginning with receipt and continuing through storage, tracking, and final disposition. We maintain strict chain‑of‑custody procedures and operate under robust SOPs covering reagent quality, equipment metrology, and raw data controls, ensuring complete traceability and compliance.

Medical Writing Support

  • Cliantha provides comprehensive medical writing support for bioanalytical studies, including the preparation of sample analysis reports, method validation reports, and other regulatory‑driven documentation. Each report undergoes multiple levels of scientific and quality review and is typically delivered within 2–5 weeks following final data QC, ensuring clarity, consistency, and regulatory readiness.
  • Value to you: Reliable exposure data to guide critical development decisions

Immunogenicity Testing (ADA & NAb)

Immunogenicity is a critical component of biologics and vaccine development. Our comprehensive strategies assess both binding and functional immune responses to ensure patient safety and therapeutic efficacy.

ADA Capabilities

  • Screening, confirmatory, and titration assays
  • Bridging ECL and direct ELISA formats
  • Cut point establishment, sensitivity, and drug tolerance evaluation
  • Mitigation of drug, target, and matrix interference
  • Experience with interference issues, mitigation strategies, and/or binding components
  • Acid dissociation, SPEAD, ACE, PandA
  • Physical separation by size exclusion or magnetic protein A/G
  • In-house labeling of antigen with biotin and sulfo-TAG
  • Assay validation in line with FDA immunogenicity guidance
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NAb Capabilities

  • Mechanism of action driven neutralizing antibody assays
  • Cell based and competitive ligand binding formats
  • Sensitivity and drug tolerance assessment
  • Clinical sample analysis and data interpretation

Experience includes

  • Monoclonal and bispecific antibodies, fusion proteins, PEGylated proteins
  • Peptides, endogenous analogs, ADCs, oligonucleotides
  • Studies in healthy volunteers and patient populations

Our Edge in Immunogenicity Testing

ADA assay development and validation, Neutralizing Antibody (Nab) Assays, Advanced Immunoassay Platforms, Regulatory & Quality Compliance, and Comprehensive Study Support, GCLP compliance Sample management and critical reagent lifecycle management system.

Testing Platforms

MESO QuickPlex SQ 120MM Plate Reader, SpectraMax iD3 Microplate Reader, SpectraMax ABS Microplate Reader, Biotek ELx50 Microplate Washer.

Biomarker assays

Biomarkers are central to modern drug development. As an end to end global CRO, Cliantha provides biomarker testing solutions that help sponsors generate high quality, interpretable data from discovery through late phase trials and post marketing programs.

Comprehensive Biomarker Solutions

Cliantha supports biomarker strategies across therapeutic areas and study phases, including:

  • Exploratory biomarkers for hypothesis generation and early clinical insights
  • Pharmacodynamic (PD) biomarkers to demonstrate target engagement and biological activity
  • Predictive and prognostic biomarkers to inform patient selection and trial enrichment
  • Safety biomarkers to support risk monitoring and benefit–risk evaluations
  • Translational biomarkers bridging preclinical findings to clinical outcomes

Platforms & Technologies

Our laboratories leverage fit for purpose platforms to match biomarker complexity, sample types, and required sensitivity:

  • Immunoassays (ELISA, MSD/ECL, CLIA/CMIA, where applicable)
  • Multiplex biomarker panels for cytokines, chemokines, and soluble markers
  • Flow cytometry / immunophenotyping for cell based biomarkers and immune monitoring
  • Chromogenic and functional assays for pathway activity and coagulation-related markers
  • Cell based assays for functional readouts when mechanism requires biological response measurement
  • Hematology parameters
  • End point and kinetic assays for Special Chemistry parameters
  • Platelet function assays
We support commonly used matrices including serum, plasma, whole blood, urine, and other study relevant biospecimens, with standardized handling aligned to study design.

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)

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 Vaccine Program

    Cliantha Vaccines can help you implement a testing strategy that is robust, scalable, and submission supportive.

Cell based assays

Cell based assays provide robust, biologically meaningful insights into how vaccines, biologics, and biosimilars behave in physiologically relevant systems. At Cliantha, we offer an advanced suite of cell based functional assays designed to measure immune activation, pathway modulation, and functional antibody responses , vaccine potency : all developed under approved, documented, regulatory-aligned processes.

Our capabilities support exploratory through late phase clinical programs, ensuring sponsors receive high quality, decision ready data.

Neutralizing Antibody (NAb) Assays

Neutralizing antibody assays are essential for determining whether antibodies generated in response to vaccines or biologics block the biological function of the target antigen. Cliantha offers a comprehensive portfolio of NAb assays tailored to program needs.

NAb Assay Formats

Surrogate / Competitive NAb Assays

  • High throughput
  • Ideal for large clinical studies
  • Measures inhibition of receptor–ligand or antigen–antibody interaction

Cell Based NAb Assays

  • Measures functional neutralization through physiologically relevant mechanisms
  • Supports regulatory expectations for functional immunogenicity assessments

Live Virus Neutralization Assays (where applicable)

  • Gold standard for functional neutralization
  • Performed under appropriate biosafety and regulatory controls

NAb Assays as Part of Immunogenicity Testing for Biosimilars

For biosimilars, immunogenicity evaluation is essential to demonstrate similarity to the reference product. At Cliantha, NAb assays are integrated into a structured, tiered immunogenicity testing approach, ensuring that binding and neutralizing antibody responses are detected, confirmed, and interpreted accurately.

    Our Tiered Immunogenicity Workflow for Biosimilars

  • 1. Screening ADA (Binding Antibodies)
  • Confirmatory Assay to assess specificity
  • Titer Determination for longitudinal monitoring
  • Neutralizing Antibody (NAb) Assay to evaluate functional impact

Our Biosimilar Focused NAb Capabilities

  • Cell based functional NAb assays
  • Surrogate/competitive NAb assays
  • Assay bridging between biosimilar and reference product
  • Fit for purpose qualification and full validation

This ensures regulatory aligned, scientifically defensible immunogenicity packages for global biosimilar submissions.

Broader Cell Based Functional Assays

Beyond NAb testing, Cliantha provides a wide range of functional assay platforms:

  • Cytopathic effect (CPE) assays
  • Cell mediated immunity (CMI) functional assays
  • Cytokine release & immune activation assays
  • Antibody dependent cellular cytotoxicity (ADCC)
  • Complement dependent cytotoxicity (CDC)
  • Cell based potency assays

These support mechanism of action studies, potency evaluation, safety endpoints, and advanced functional characterization.

    Assay Development, Qualification & Validation

    All assay development and validation activities follow well documented, protocol driven workflows aligned with industry standards and regulatory guidance.

    We offer:

  • Assay development & optimization
  • Fit for purpose qualification
  • Full validation for clinical use
  • Matrix and interference assessments
  • Stability and robustness evaluations
  • Lot to lot and platform bridging studies

    Why Sponsors Choose Cliantha for Cell Based & NAb Testing

    All assay development and validation activities follow well documented, protocol driven workflows aligned with industry standards and regulatory guidance.

    We offer:

  • Specialized expertise across vaccines, biologics, and biosimilars
  • Comprehensive immunogenicity testing with integrated NAb workflows
  • Regulatory aligned processes and audit ready documentation
  • Scalable capacity to support global late-phase trials
  • End to end support through Cliantha’s global CRO infrastructure
  • High scientific rigor with rapid, reliable turnaround

Research delivered with Integrity

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