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

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