Which Anti-Drug Antibody (ADA) Assays, Neutralizing Antibody (nAb) Assay, And Risk Based Immunogenicity Assay Services Do We Offer?
Advanced Anti-Drug Antibody (ADA) Assays Development, Neutralizing Antibody (nAb) Assay Development, And ADA/nAb Assay Validation Services CRO For Your Immunogenicity Assessment!
ADA Assay Development, Optimization, Or Method Transfer For Biologics, Cell Therapy, Gene Therapy, etc.
- Bridging Anti-Drug Antibody Assay Development On Meso Scale Discovery Or ELISA For MAb, Peptide, ScFv, or Protein, With In-House Tagging (Ruthenylation, Biotinylation) Of Critical Reagents
- Drug Tolerance Improvement Using Acid Dissociation, Solid-Phase Extraction With Acid Dissociation (SPEAD), Affinity Capture Elution (ACE), Biotin-Drug Extraction And Acid Dissociation (BEAD), Precipitation And Acid Dissociation (PandA), Etc
Fit-For-Purpose or GLP Anti-Drug Antibody Assay Validation
- High-Quality ADA Assay Validation Based on a Multi-Tiered Approach, i.e., Screening, Confirmation, And Titration Cut Point as Per FDA’s Guidance On Immunogenicity Testing of Therapeutic Protein Products
- ADA Method Validation Plan Approved in Advance For Sponsor Feedback On Crucial Decisions, Such as Diseased vs. Healthy population, # of selectivity and specificity testing lots for preclinical vs. clinical testing
Risk Based Immunogenicity Assessment For Preclinical Or Clinical Samples
- Reliable, Multi-Tiered Sample Analysis with Initial Screening, Followed By Confirmation, And Titration Driven by Floating Assay Cut points
- Specifically, i) ADA screening assay to detect high and low-affinity anti-drug antibodies, ii) ADA Confirmatory assay to eliminate false positives from nonspecific binding, iii) ADA Titer assay to determine the magnitude of ADA response, and iv) ADA neutralizing antibody (NAb) assay to characterize the neutralizing activity
Cell-Based Neutralizing Antibody Assay Development Or Competitive Ligand Binding nAb Assay Development
- Indirect or Direct Cell-Based Neutralizing Antibody Assay based on observed cellular response and your therapeutic’s mechanism of action as well as agonistic or antagonistic properties
- Reproducible Non Cell-Based, Competitive Ligand Binding Assay for soluble receptors or receptor-Fc fusion MAb and proteins with humoral targets to detect the Nab incidence and characterize the immune response as either neutralizing (NAb-positive) or non-neutralizing (NAb-negative)
Fit-For-Purpose or GLP Neutralizing Antibody Assay Validation
- Robust nAb Assay Validation With NAb-specific assay tiers (i.e., screen, confirm, titer) for high-risk biologic products homologous to endogenous protein with non-redundant function, where NAbs may cross react with the endogenous counterpart and can have critical safety consequences
- nAb Method Validation Plan Approved in Advance For Sponsor Feedback On Crucial Decisions, Such as i) format selection; ii) cut point assessment; (iii) acceptance criteria; iv) sensitivity including positive control and negative control selection; v) selectivity/specificity; vi) drug tolerance; vii) target tolerance, etc
Neutralizing Antibody Assays for Cell and Gene Therapy (CAR-T) Applications
- AAV Neutralizing Antibody (NAb) Assay to assess transduction inhibition of AAV resulting from the presence of anti-AAV Neutralizing antibodies
- Custom Neutralizing antibody assay, including parallel NAb-specific assay tiers (i.e., screen, confirm, titer). testing flow where NAb is used for trial inclusion/exclusion purposes, or to support otherwise high-risk products