Comprehensive ADA Immunogenicity Testing to Ensure Biologic Safety and Efficacy
Accelevir delivers fully integrated ADA immunogenicity testing across all stages of drug development—from candidate screening and assay development to regulatory filings and post-market surveillance. Our multi-platform strategy, coupled with expert bioanalytical insight, empowers biotech and biopharma innovators to de-risk immunogenicity and meet global regulatory requirements.
- GLP/GcLP-compliant ADA and NAb assay platforms
- Plate-based, cell-based, and flow cytometry formats
- Acid dissociation and SPEAD drug-tolerant methods
- Study coordination, PBMC processing, and high-throughput sample handling
Explore our Immunogenicity Testing Services or Start Your Project.
What Is ADA Immunogenicity?
ADA (Anti-Drug Antibody) immunogenicity occurs when the immune system recognizes therapeutic biologics as foreign and generates antibodies against them. This immune response can reduce drug efficacy, alter pharmacokinetics, and in some cases, cause serious adverse events. Immunogenicity testing is the gold standard for evaluating these effects during preclinical and clinical development.
Impact of Immunogenicity:
- Accelerated drug clearance and decreased bioavailability
- Reduced or nullified pharmacological effect (via NAbs)
- Safety concerns including hypersensitivity, autoimmunity, and infusion reactions
- Challenges in biosimilar comparability and regulatory approval
Why ADA Testing Matters
Leading regulatory bodies such as the FDA, EMA, and ICH mandate ADA testing as part of the drug development process. Guidelines require:
- ADA screening, confirmation, and characterization
- Neutralizing antibody evaluation when ADA is detected
- Assessment throughout Phases I–IV
- Justification of ADA impact on PK, PD, safety, and efficacy
Robust ADA testing is especially crucial for biologics like mAbs, enzymes, fusion proteins, gene therapies, and oligonucleotide drugs.
ADA Assay Workflow: A Tiered Testing Strategy
Accelevir uses a risk-based, multi-tiered immunogenicity assay workflow:
- Screening Assay: High-sensitivity detection of ADAs (ELISA, MSD)
- Confirmatory Assay: Validates specificity via competitive inhibition
- Characterization Assay: Measures ADA titer, isotype, and persistence
- Neutralizing Antibody (NAb) Assay: Evaluates neutralizing function using cell-based or ligand-binding formats
- Drug Tolerance Enhancements: Acid dissociation, SPEAD, ACE workflows
Each tier adheres to regulatory expectations and is adapted to the molecule’s structure, MOA, and intended clinical use.
Advanced Platforms & Technologies
Accelevir supports ADA testing with:
- ELISA, MSD/ECL, and Gyrolab®: Plate-based, high-throughput screening
- Cell-based bioassays: Functional analysis of neutralization potential
- Flow Cytometry (CytoFLEX): Up to 9-color panels for isotyping, cytokine profiling, and functional T cell assays
- PCR-based Molecular Assays: To evaluate ADA impact on gene expression
- Acid Dissociation, SPEAD, ACE: Drug-tolerant detection options
Our custom workflows are powered by a CLIA-certified, high-complexity immunology lab equipped with RoboSep™, Bio-Rad ddPCR, ThermoFisher Qubit, and more.
ADA/NAb Testing Capabilities
- Binding ADA detection (bridging ELISA, ECL, Gyrolab®)
- NAb detection (reporter gene, cell-based cytotoxicity, ligand-competition)
- Isotyping: IgG subclasses, IgM, IgE
- Titering: Longitudinal immune profiling
- PK/PD integration: Drug exposure vs. immune response
- Cross-reactivity mapping across related molecules or biologic variants
We support testing for gene therapies, monoclonals, vaccines, fusion proteins, and oligonucleotide therapeutics.
Preclinical & Clinical Program Support
Accelevir supports full-phase ADA testing across:
- Discovery and candidate selection (early immunogenicity risk profiling)
- GLP-compliant preclinical studies
- Clinical trials (Phases I–IV, post-market surveillance)
- Biosimilar comparability exercises
- PK/PD bridging and assay cross-validation
We provide consultative assay development, data analytics, and regulatory-ready documentation.
Custom ADA Assay Development & Validation
We provide:
- De novo assay development based on molecule structure and clinical indication
- Positive control antibody generation (anti-idiotype, polyclonal)
- Regulatory-grade validation: sensitivity, precision, accuracy, LLOQ, ULOQ, cut-points
- Full GLP/GcLP compliance, method bridging and technology transfer support
Our ADA/NAb assays are optimized for high-throughput analysis with precise batch-to-batch reproducibility.
Regulatory Compliance & Documentation
- FDA (2009+), EMA (2007/2012), ICH S6(R1) alignment
- Study design and assay method justification
- Data integrity and audit trails (21 CFR Part 11 compliant)
- Comparator testing for EUA/510(k) or biosimilar programs
We partner closely with regulatory consultants and client sponsors to ensure readiness at every phase.
Broader Capabilities to Support Your Program
In addition to ADA testing, Accelevir offers:
- Flow Cytometry Services
- Cytotoxicity & Functional Immune Assays
- Molecular Assay Development
- Gene Therapy Vector Characterization
- PBMC Isolation & Cell Banking
- Digital PCR & qPCR Assay Services
Frequently Asked Questions (FAQs)
When should I begin ADA assay development?
Begin in preclinical development or early IND-enabling studies to avoid costly rework and meet regulatory expectations.
How do you differentiate binding ADA from NAbs?
Binding ADA assays measure presence; NAb assays evaluate biological inhibition. Both are required when immunogenicity risk is high.
What platforms are best for low-abundance ADA detection?
Electrochemiluminescence (ECL) and Gyrolab® offer high sensitivity with low matrix interference, ideal for low-abundance ADA or early-stage studies.
Do I need drug-tolerant ADA assays?
Yes, if your therapeutic has high circulating concentrations or low immunogenicity. Techniques like acid dissociation or SPEAD help uncover hidden responses.
How long does ADA assay development take?
Timelines vary from 6 to 12 weeks depending on complexity, controls, and matrix type. Early planning helps accelerate go-to-clinic timelines.
Speak with Our ADA Assay Experts
Protect your therapeutic investment with expert immunogenicity testing. Accelevir’s ADA assay services deliver the scientific rigor, regulatory compliance, and operational agility needed to advance your program.