Immunogenicity Testing Services
Immunogenicity refers to the ability of a therapeutic substance to elicit an immune response in treated individuals. For biologics, gene therapies, peptides, and oligonucleotide-based therapeutics, this immune response can lead to the formation of anti‑drug antibodies (ADAs) and, in some cases, neutralizing antibodies (NAbs). Detecting and understanding these responses is essential for ensuring patient safety, drug efficacy, and overall program success.
Mercodia provides regulatory‑compliant immunogenicity testing services supporting both preclinical and clinical development.
With extensive experience in ADA assay development, validation, and sample analysis, we deliver high‑quality immunogenicity data tailored to your molecule and study phase.
Mercodia delivers phase- and drug- appropriate immunogenicity solutions designed for your specific molecule.
By balancing scientific integrity with tailored risk-based immunogenicity assessment designs, we minimize redundant testing while ensuring scientific rigor and regulatory success.
Why is it important to measure immunogenicity?
Therapeutic proteins, antibodies, peptides, and oligonucleotide‑based drugs have the potential to induce anti‑drug antibodies (ADAs). The clinical consequences of these immune responses can vary widely.
Immunogenicity can influence therapeutic performance and data interpretation in several ways:
- Reduce or eliminate drug efficacy
- Alter pharmacokinetics (PK) and pharmacodynamics (PD) by decreasing or increasing half‑life
- Cause adverse effects or loss of therapeutic response
- Interfere with drug quantification in PK assays
- Have no clinical effect
Because of these potential risks, immunogenicity assessment is a regulatory requirement for therapeutic protein products and an increasingly important consideration for gene therapies and oligonucleotide‑based therapeutics.
Types of immunogenicity assays
Anti-Drug Antibody (ADA) Assays
Anti‑drug antibodies can affect drug exposure, safety, and clinical interpretation. Mercodia offers ADA assays built on ELISA and MSD platforms, including:
- Screening assays to identify potential ADAs
- Confirmatory assays to verify specificity
- Titer assays for semi‑quantitative estimation of ADA levels
Our ADA assays are optimized for sensitivity, reproducibility, and matrix tolerance.
Neutralizing Antibody (NAb) Assays
Neutralizing antibodies can block the pharmacological activity of a therapeutic molecule. Mercodia provides:
- Ligand‑binding NAb assays, suitable when a functional cell‑based readout is not required
- Cell‑based NAb assays, used when assessing functional impact is necessary
our immunogenicity testing services
Assay Development & Validation
- Customized ADA and NAb assay design
- Fit‑for‑purpose or fully validated methods following FDA/EMA recommendations
- Platforms: Ligand‑binding assays (ELISA, MSD) and SPR‑based interaction analysis using Biacore™ systems
Preclinical Immunogenicity Testing
- Flexible strategies including streamlined 1‑tier approaches for low-risk or exploratory studies
- Early assessment of immune response in animal models
Data Interpretation & Reporting
- Clear, regulatory‑ready documentation for global submissions
Clinical Sample Analysis
- ADA and NAb detection in healthy volunteers or patient populations
- Longitudinal monitoring across all clinical phases
- Drug‑tolerant, high‑sensitivity assay formats
- Full multi‑tier ADA workflows: screening → confirmatory → characterization (titration/neutralization assays/other characterizations)
- Simplified approaches for low‑risk or early‑phase programs
Our expertise
Mercodia has extensive experience delivering ADA analysis for both preclinical and clinical programs across a range of therapeutic modalities.
We work across:
- Humanized monoclonal antibody candidates
- Recombinant protein/peptide therapies
- Medical device‑related biologics
We have deep expertise in tech transfer, assay optimization, and validation, including transitioning assays from non‑human primates to humans, critical in first‑in‑human (FIH) studies. Our work spans multiple therapeutic areas, including metabolic diseases, regenerative medicine, autoimmune disorders, and inflammatory conditions.
Partner with Mercodia
Whether you are initiating a preclinical study or preparing a pivotal clinical submission, Mercodia provides reliable, regulatory‑compliant immunogenicity testing services to support your development pathway.
Contact us to discuss your project and receive a tailored proposal.
