Immunogenicity Testing Services
Immunogenicity testing consists of the measurement of antibodies generated against a drug treatment and helps determine its safety and efficacy. These tests are mandatory for therapeutic proteins in clinical studies and, based on scientific rationale, may also be applied in preclinical studies and for peptide and oligonucleotide therapeutics.
Mercodia offers a range of validated assays for the detection and confirmation of Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs), supporting both preclinical and clinical studies. With years of experience in immunogenicity testing, we provide validated, regulatory-compliant testing solutions tailored to your program.
Our immunogenicity services
Mercodia offers a comprehensive suite of immunogenicity testing services to support your drug development program. We help pharmaceutical and biotech companies assess the immunogenic potential of proteins, biosimilars, peptides, and oligonucleotide therapeutics.
Our team has extensive experience in ligand binding assays and works closely with clients to tailor assay formats to the molecule and study phase. All services are performed in our GLP-approved laboratory, following ICH GCP, EMA, and FDA guidelines. Whether you’re in early development or preparing for regulatory submission, we provide reliable data and long-term assay support.
Our service includes
Assay development & validation
- Customized ADA and NAb assay design
- Fit-for-purpose validation aligned with FDA and EMA recommendations
- Platforms: ELISA, Meso Scale Discovery (MSD), cell-based reporter assays
Preclinical immunogenicity testing
- Flexible testing strategies, including simplified 1-tier approaches for low-risk or exploratory studies
- Early evaluation of drug exposure and immune response in animal models
Clinical sample analysis
- ADA and NAb detection in healthy volunteers and patients
- Longitudinal monitoring across study phases
- High-sensitivity assays tolerant to circulating drug
- Multi-tier or simplified approaches tailored to study phase and risk level
- Multi-tier approach: Screening, confirmatory assays, and characterization where relevant
- Simplified approach: Streamlined ADA testing for low-risk or early-stage studies
Data interpretation & reporting
- Regulatory-ready reports supporting global submissions
Mercodia immunogenicity testing services help you de-risk development, meet regulatory expectations, and accelerate decision-making.
Anti-Drug Antibody (ADA) Assays
ADAs are a common immune response to biologic drugs and can interfere with drug efficacy or cause adverse effects. Mercodia offers a tiered ADA testing strategy using ELISA or MSD platforms:
- Screening Assay – Detects potential ADAs
- Confirmatory Assay – Verifies ADA specificity
- Titer Assay – Quantifies ADA levels
Our assays are optimized for sensitivity, reproducibility, and regulatory compliance.
Neutralizing Antibody (NAb) Assays
NAbs can block the therapeutic effect of a drug, making their detection essential in immunogenicity risk assessment. Mercodia provides ligand binding-based NAb assays suitable for molecules where cell-based formats are not required.
We work closely with clients to determine the most suitable assay format and can support integration with external neutralizing antibody (NAb) data when needed.
Partner with Mercodia
Whether you are in early development or conducting pivotal clinical trials, Mercodia delivers reliable, regulatory-compliant immunogenicity testing to support your program.
Contact us to discuss your project and receive a tailored proposal.
