Immunogenicity
De-Risk Your Program with World-Class ADA and nAb Expertise.
15+ years of immunogenicity experience, a first global Gyrolab® Certified CRO with multiple certified labs, and regulatory-ready data across every biologic modality.
De-Risk Your Therapeutic Development with Expert Immunogenicity Testing
Global immunogenicity expertise for biologics,
gene therapies, biosimilars, and emerging modalities. decisions, and bring innovative therapies to patients with confidence.
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
Lab Expertise
Our Fordham and Malvern sites are both a Gyrolab Certified CRO Partner.
Our Fordham site is Certified Service Provider Status on Ella™ Platform
Ready to build a robust immunogenicity strategy for your programme?
Partner with one of the world’s most comprehensive immunogenicity networks, delivering ADA and nAb assays
with the scientific depth, platform breadth, and regulatory track record your development programme demands.
Our Bioanalytics Resources
Case Studies
Faster, Simpler Oligonucleotide Quantitation: An Extraction-Free qPCR Workflow for Tissue and Plasma
Case Studies
One Picogram Per Millilitre: Quantifying Free MMAE in Human Plasma for ADC Clinical Studies
Case Studies
Immunogenicity in the Age of siRNA: Developing ADA Assays for GalNAc-Conjugated siRNA Therapeutics
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