Immunogenicity
Developing, validating and implementing anti-drug antibody (ADA) immunogenicity and neutralizing antibody (nAb) assays.
Your Partner for Regulatory-Ready Immunogenicity Data
We deliver comprehensive immunogenicity assessments across all therapeutic modalities, ensuring regulatory-ready data that keeps your program moving forward.
Our Expertise
- 15+ years of dedicated ADA and nAb experience with proven EMA and FDA submission success
- Multi-modality capabilities: mAbs, bispecifics, tri-specifics, Ab fragments, peptides, AAV gene therapies, expressed transgene products, ADCS, oligonucelotides, and biosimilars
- Advanced characterization: Domain specificity mapping for bispecifics, isotype profiling, and nAb assessments for complex modalities
- Flexible method development:
MSD, Gyrolab, AlphaLISA, and ELISA platforms tailored to your molecule - Global Gyrolab® Certified CRO Partner:
First global CRO with multiple certified Gyrolab® labs (UK and US sites) - Tiered clinical approaches with fit-for-purpose preclinical strategies that accelerate development
Your Partner
Resolian operates one of the world’s most comprehensive immunogenicity networks:
- Global reach: Dedicated labs across the UK, USA, Australia, and China
- Collaborative approach: We don’t just run assays – we design the right strategy, from characterizing domain specificity in bispecifics to assessing anti-AAV immunity in gene therapies
- End-to-end capabilities: In-house critical reagent generation, automated sample pre-treatment, and dedicated statistics support
- Industry expertise: Our scientists contribute to EBF, Reid, and immunogenicity forums, keeping our methods aligned with evolving regulatory standards
Services
- Assay development, validation and sample analysis
- Pre-clinical and clinical immunogenicity and nAb assays
- Ligand binding and cell-based assays
- Acid dissociation
- ACE
- SPEAD
- Isotyping assays
Therapeutic Modalities
- Monoclonal antibodies (mAbs)
- Antibody fragments (Fab, nanobody, domain Abs)
- Antibody drug conjugates (ADCs)
- Proteins
- Peptides
- Bispecifics
- Biosimilars
- AAVs, gene therapy
Technologies
- ELISA (absorbance, luminescence, fluorescence)
- GyroLab xPand, xPlore™
- Quanterix (HDX Simoa)
- Electrochemiluminescence (MSD Sector Imager 6000, QuickPlex)
- Luminex (Magpix, Flexmap 3D)
- Flow cytometry (Beckman Coulter CytoFLEX)
- qPCR (QuantStudio™ 7) and Hybridization ELISA
- Luminex Flexmap 3D
- Protein Simple Ella
- Thermo Scientific NanoDrop
- Hamilton STAR Robotics
De-Risk Your Therapeutic Development with Expert Immunogenicity Testing
Global immunogenicity expertise for biologics, gene therapies, biosimilars, and emerging modalities.
Our Bioanalytics Resources
Case Studies
Development and Validation of an Immunogenicity Assay for Detection of Anti-AAV Antibodies
