Anti-Drug Antibody (ADA) Testing

Accurate and Rapid Anti-Drug Antibody (ADA) Testing for Preclinical and Clinical Programs

Accelevir delivers advanced anti-drug antibody (ADA) detection and immunogenicity assessment services tailored to support your biotherapeutic development from discovery through commercialization. Our CLIA-certified laboratory combines immunoassay development, expert consultation, and regulatory-aligned documentation to guide ADA evaluation with precision.

We support a wide range of biologics and therapeutic modalities including monoclonal antibodies, gene therapies, recombinant proteins, biosimilars, and cell therapies.

• Customized ELISA, ECL, and cell-based ADA assays
  
• ADA screening, confirmation, characterization, and neutralization
  
• Support for regulatory filings: IND, BLA, biosimilar applications
  
• Integrated PK/PD, safety, and immunogenicity workflows

Request a Quote | Consult with an ADA Expert

What Are Anti-Drug Antibodies (ADAs)?

Anti-drug antibodies are immune responses developed by patients against biologic or gene therapy products. ADAs can impact therapeutic outcomes by neutralizing drug activity, altering pharmacokinetics, or inducing immune-mediated side effects.

Types of Anti-Drug Antibodies:

• Neutralizing ADAs (NAbs): Block therapeutic function by binding to the active site
  
• Non-neutralizing ADAs: Bind to other epitopes but may accelerate drug clearance
  
• Complex-specific ADAs: Target drug-antigen complexes; used for specific quantification
  
• Cross-reactive ADAs: Recognize both therapeutic and endogenous proteins, raising safety risks

Clinical Impact:

• Loss of efficacy or non-responsiveness
  
• Hypersensitivity reactions or anaphylaxis
  
• Altered drug pharmacokinetics and half-life
• Regulatory hurdles for product approval

ADA testing is a regulatory requirement for all therapeutic biologics and a key component of clinical trial safety and efficacy evaluation.

Applications of ADA Testing and Immunogenicity Assessment

• Preclinical Immunogenicity Screening: Early detection of immunogenic risks in candidate molecules
  
• Clinical Immunogenicity Monitoring: Real-time ADA detection during Phase I–III trials
  
• Pharmacokinetics and Pharmacodynamics (PK/PD) Analysis: Assess impact on exposure and drug action
  
• Biosimilar Comparability: Demonstrate ADA equivalence to originator biologics
  
• Regulatory Submissions: Support IND, BLA, and EMA filings with complete immunogenicity packages
  
• Post-Market Surveillance: Ongoing monitoring to detect delayed or rare ADA events
  
• Personalized Medicine Strategies: Monitor ADA formation to guide dosing or therapeutic switching

ADA Assay Development & Analytical Workflow

Accelevir designs and qualifies ADA testing strategies that align with regulatory guidance and client needs.

Assay Platforms Supported:

• ELISA: Direct, bridging, and competitive assays for total ADA detection
  
• Electrochemiluminescence (ECL): Increased sensitivity and drug tolerance
  
• Radioimmunoassay (RIA): Available for specific formats on request 
• Cell-Based Neutralization Assays: Assess functional impact on therapeutic activity
  
• Flow Cytometry-Based Neutralization: Functional profiling of immune cell responses

End-to-End Workflow:

1. ADA Screening: Detect presence of binding antibodies
   
2. Confirmatory Assays: Distinguish specific from non-specific binding
   
3. Characterization Assays: Determine titer, isotype, and persistence
   
4. Neutralizing Antibody Testing: Evaluate impact on therapeutic function
   
5. Custom Assay Development: For novel biologics and cell/gene therapies

Anti-Idiotypic Antibody Generation for PK & ADA Assays

To support high-sensitivity assay performance, Accelevir develops custom anti-idiotypic antibodies:

• Monoclonal (hybridoma and phage display) and polyclonal formats
  
• Blocking, non-blocking, and complex-specific anti-IDs
  
• ELISA-ready antibody panels with QC validation
  
• Available labeling: biotin, HRP, fluorophores, etc.
  
• Monoclonals delivered in as little as 8 weeks
  

Anti-ID antibodies support both total drug and free-drug quantification as well as ADA neutralization assessment.

Sample & Study Management Services

Efficient sample handling and logistics support reliable longitudinal ADA analysis:

• Serum and plasma collection protocol support
  
• Timepoint-based sampling strategies
  
• Long-term storage and chain-of-custody integrity
  
• PBMC isolation and cryopreservation
  
• Integration with cell bank and PBMC processing capabilities

Regulatory & Quality Compliance

Our ADA testing services adhere to international regulatory and quality standards:

• CLIA-certified laboratory environment
  
• GLP-compliant SOPs and documentation
  
• Assay validation aligned with:
  
  • FDA Immunogenicity Guidance
    
  • EMA/CHMP/BMWP guidelines
    
  • ICH S6/S6(R1)
    
• IND/BLA-ready reports and statistical analysis

Full traceability, data integrity, and electronic records ensure audit readiness and global regulatory alignment.

Broader Capabilities to Support Your Program

Accelevir integrates ADA services within a comprehensive immunology and molecular testing platform:

• Immunogenicity Testing
• Flow Cytometry Services (9-color phenotyping)
  
• Cytotoxicity Testing
• Molecular Assay Development
• Gene Therapy Services
• Cell Banking and Processing

Why Choose Accelevir for Anti-Drug Antibody Services?

Scientific Leadership

• Decades of experience in virology, immunology, and bioanalytical assay development
  
• Custom ADA assay design for protein, cell, and gene-based therapeutics

Fast Turnaround & Tailored Support

• Rapid antibody development timelines
  
• Fit-for-purpose ADA solutions for preclinical, clinical, and post-market programs

End-to-End Program Alignment

• Integrated immunogenicity, PK/PD, and toxicology workflows
  
• Regulatory consultation and data package preparation

Cutting-Edge Platforms

• Digital PCR, high-throughput ELISA, flow cytometry, and next-generation sequencing

Let’s Advance Your ADA Program

Accelevir delivers scientifically rigorous, highly customizable ADA testing solutions to support your therapeutic success. Whether you’re in discovery, preclinical, or late-stage development, our team partners with you for reliable immunogenicity data, faster development timelines, and confident regulatory submissions.

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Frequently Asked Questions

What’s the difference between neutralizing and non-neutralizing ADAs?

Neutralizing ADAs block drug activity by preventing binding to the target. Non-neutralizing ADAs bind the drug but may affect pharmacokinetics or cause immune reactions.

How do you test for ADA during a clinical trial?

We use a tiered strategy: screening → confirmation → characterization → neutralization. We also align sample collection to key trial timepoints.

Can you detect ADA in the presence of circulating drug?

Yes. We use drug-tolerant assay formats and sample pretreatment techniques to overcome interference.

What regulatory standards do you follow?

Our assays follow FDA, EMA, and ICH S6/R1 guidelines with full documentation for IND, BLA, and biosimilar submissions.

Do you offer integrated PK/PD and ADA analysis?

Yes. We provide customized bioanalytical workflows that connect ADA results to pharmacokinetics and pharmacodynamics.