The Sword Difference
At Sword Bio, our scientists have the experience and expertise to tackle the complexities that are a part of developing ADA and NAb assays, one of which is drug tolerance.
Our scientists have knowledge of immunogenicity of biotherapeutics as well as gene therapy vectors (AAVs) and can get you the immunogenicity information you need
Comprehensive Immunogenicity Strategy Across Development Stages
Immunogenicity risk evolves as programs advance from preclinical studies into clinical trials. Sword Bio applies a fit-for-purpose, multiphase immunogenicity strategy that aligns assay rigor with stage of development and regulatory expectations.
During early nonclinical studies, our focus is on rapid assay development and qualification to support candidate selection and risk assessment. As programs transition into IND-enabling and clinical stages, we expand assay validation and introduce GLP-compliant workflows to ensure data integrity and regulatory readiness.
Our scientists work collaboratively with sponsors to define assay acceptance criteria, sampling strategies, and mitigation approaches Avoiding over- or under-engineering assays early on.
ADA Assay Formats & Drug Tolerance Solutions
Sword Bio has experience developing both bridging and direct-binding ADA assays, selecting formats based on therapeutic structure, expected immunogenicity profile, and interference risks. Bridging assays are commonly used for bivalent antibodies, while direct-binding formats are better suited for monovalent or structurally complex therapeutics.
Drug tolerance is a central challenge in ADA testing. To address this, we implement advanced drug-tolerant methodologies, including:
- Acid dissociation formats to dissociate ADA–drug complexes
- Affinity Capture Elution (ACE) and Solid-phase extraction with acid dissociation (SPEAD) for enhanced drug tolerance
- Optimization of incubation conditions and reagent concentrations to maximize sensitivity
These approaches enable accurate ADA detection even in the presence of high circulating drug levels.
Neutralizing Antibody (NAb) Assays
In addition to binding ADA assays, Sword Bio develops and validates both solution-based and cell-based receptor NAb assays. NAb assays are designed to assess the functional impact of antibodies on drug activity, making them a critical component of immunogenicity risk assessment.
Our NAb capabilities include:
- Ligand–receptor inhibition assays
- Integration with ADA workflows to support tiered immunogenicity testing strategies
For gene therapy programs, we also support AAV vector immunogenicity screening, including detection of pre-existing and treatment-induced antibodies that may impact efficacy or safety.
How Our Team Can Help
We have experience developing both bridging and direct-binding ADA, solution based Nab assays, as well as the more drug tolerant ACE and SPEAD formats. Multiphased approach to include:
- Method development, qualification, validation and sample testing support
- Screening assay and cut point determination
- Confirmatory assay development
- Drug tolerance interference mitigation
- Isotype evaluation
- AAV vector immunogenicity screening
- Solution based Nab assays
- Cell-based receptor Nab assays
- Non-clinical and Clinical services
- Non-GLP or GLP