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 ADAs. The clinical consequences of these immune responses can vary widely and may include:
- Have no clinical effect
- Reduce or eliminate drug efficacy
- Alter drug 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
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.
Understanding ADA measurements
Unlike PK, PD, and biomarker assays, ADA assays do not determine antibody concentrations. Instead, ADA assessment relies on a qualitative and semi-quantitative testing strategy, consistent with current regulatory guidance. ADA analysis relies on:
- Tiered testing workflows to efficiently identify and confirm true ADA-positive samples
- Titration (semi‑quantitative) to estimate antibody levels in confirmed positive samples
- Low‑throughput analysis due to multiple dilution steps in titration tier
This approach ensures sensitive, specific, reproducible detection of ADAs, supporting reliable immunogenicity risk assessment and regulatory-compliant decision-making.
Our service includes
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
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
Data interpretation & reporting
- Clear, regulatory‑ready documentation for global submissions
Our expertise
Mercodia has extensive experience delivering ADA analysis for both preclinical and clinical programs across a range of therapeutic modalities, including:
- 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 projects span multiple therapeutic areas, including metabolic diseases, regenerative medicine, autoimmune disorders, and inflammatory conditions.
Types of immunogenicity assays
Anti-Drug Antibody (ADA) Assays
ADAs are a ADAs may impact drug safety, PK, PD, or efficacy and are therefore a central component of immunogenicity risk assessment. Mercodia offers robust ELISA- and MSD‑based tiered ADA assays, including:
- Screening assays – identification of potential ADAs
- Confirmatory assays – verification of ADA specificity
- Titer assays – quasi‑quantitative evaluation of ADA levels
Our assays are optimized for sensitivity, reproducibility, and matrix tolerance compliance.
Neutralizing Antibody (NAb) Assays
Neutralizing antibodies can block the pharmacological activity of a therapeutic drug.
Mercodia provides ligand‑binding NAb assays for molecules where cell‑based formats are not required, as well as cell based NAb assays when functional assessment is critical.
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.
