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Molecular & Genomic Testing
HIV Reservoir & Virology
Immunology
Sample Processing & Biobanking
Therapeutic Modalities
Accelevir delivers advanced anti-drug antibody (ADA) detection and immunogenicity assessment services tailored to support your biotherapeutic development from discovery through commercialization. Our CAP/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.
Our team partners with sponsors from IND-enabling studies through BLA submission, delivering customized ELISA, ECL, and cell-based ADA assays with integrated PK/PD, safety, and immunogenicity workflows.
Customized ELISA, ECL & cell-based ADA assays. Screening, confirmation, characterization & neutralization. IND, BLA, and biosimilar submission support.
Baltimore, MD · CAP/CLIA-certified · BSL-2+
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.
Block therapeutic function by binding to the active site of the biologic.
Bind to other epitopes but may accelerate drug clearance.
Target drug-antigen complexes; used for specific quantification.
Recognize both therapeutic and endogenous proteins, raising safety risks.
Patients may become non-responsive to therapy as ADAs neutralize drug activity.
Immune-mediated reactions, including anaphylaxis, can compromise patient safety.
ADAs can change drug exposure and half-life, affecting dosing and response.
Immunogenicity findings can delay or complicate product approval pathways.
Whether you need a preclinical screening assay or a fully validated three-tiered package for BLA submission, our team will scope the right approach in a single working session.
Early detection of immunogenic risks in candidate molecules.
Real-time ADA detection during Phase I–III trials.
Assess impact on exposure and drug action.
Demonstrate ADA equivalence to originator biologics.
Support IND, BLA, and EMA filings with complete immunogenicity packages.
Ongoing monitoring to detect delayed or rare ADA events.
Monitor ADA formation to guide dosing or therapeutic switching.
Detect presence of binding antibodies across study timepoints using validated screening assays.
Distinguish specific from non-specific binding to confirm true ADA-positive samples.
Determine titer, isotype, and persistence to inform immunogenicity risk assessment.
Evaluate functional impact on therapeutic activity using cell-based or competitive ligand-binding formats.
Purpose-built assays for novel biologics, cell, and gene therapies — including drug-tolerant formats and Affinity Capture Elution (ACE) when needed.
Direct, bridging, and competitive assays for total ADA detection.
Increased sensitivity and drug tolerance.
Available for specific formats on request.
Assess functional impact on therapeutic activity.
Functional profiling of immune cell responses.
To support high-sensitivity assay performance, Accelevir develops custom anti-idiotypic antibodies:
Hybridoma and phage display monoclonals, plus polyclonal options.
Anti-IDs tailored to total drug, free drug, and ADA neutralization assessment.
Delivered with QC validation for immediate assay deployment.
Biotin, HRP, fluorophores, and additional labels available.
Monoclonals delivered in as little as 8 weeks.
Efficient sample handling and logistics support reliable longitudinal ADA analysis.
Serum and plasma collection guidance with timepoint-based sampling strategies.
Chain-of-custody integrity and audit-ready storage management.
Integrated with our PBMC processing platform for downstream functional assays.
Connects directly with our cell banking capabilities for consistent reagent supply across studies.
Operating in a controlled, audited environment with full data integrity safeguards.
Documented procedures supporting IND/BLA-ready reports and statistical analysis.
Validations aligned with FDA Immunogenicity Guidance, EMA/CHMP/BMWP, and ICH S6/S6(R1).
Accelevir integrates ADA services within a comprehensive immunology and molecular testing platform:
Functional and binding immunogenicity assessment across modalities.
9-color phenotyping for deep immune profiling.
Functional readouts for cell-mediated killing.
Custom qPCR, ddPCR, and NGS-based assays.
Specialized support for AAV, LNP, and cell therapy programs.
Integrated PBMC isolation, cryopreservation, and cell banking.
Decades of experience in virology, immunology, and bioanalytical assay development — with custom ADA assay design for protein, cell, and gene-based therapeutics.
Rapid antibody development timelines and fit-for-purpose ADA solutions for preclinical, clinical, and post-market programs.
Integrated immunogenicity, PK/PD, and toxicology workflows with regulatory consultation and data package preparation.
Digital PCR, high-throughput ELISA, flow cytometry, and next-generation sequencing.
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.
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.
We use a tiered strategy: screening → confirmation → characterization → neutralization. We also align sample collection to key trial timepoints.
Yes. We use drug-tolerant assay formats and sample pretreatment techniques — including acid dissociation and Affinity Capture Elution (ACE) — to overcome interference.
Our assays follow FDA, EMA, and ICH S6/R1 guidelines with full documentation for IND, BLA, and biosimilar submissions.
Yes. We provide customized bioanalytical workflows that connect ADA results to pharmacokinetics and pharmacodynamics.
