Immunogenicity Assays

Immunogenicity assays for detection and confirmation of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) supporting nonclinical and clinical studies

Immunogenicity assays are integral to biologic drug development. Biotherapeutics such as proteins or antibodies or conjugated peptides or oligonucleotides can induce an immune response in the body, leading to the development of anti-drug antibodies (ADAs) which can potentially threaten patient safety. Assessment of ADAs as well as neutralizing antibodies (NAbs), which may inhibit the biologic activity of the drug, form a fundamental part of immunogenicity testing.

Immunogenicity assays can be challenging due to interferences originating from the sample matrix, drug interference or target interference. You will need to obtain rigorous data achieved through highly sensitive and precise assays. Selection of the correct positive control, assay format, and assay optimization may all present challenges. Refinement of the assay may be needed to ensure suitability throughout the development lifecycle and post-marketing surveillance. As such, you will need an experienced partner to develop and implement your immunogenicity testing strategy to meet all safety and regulatory requirements.
Our immunogenicity assay experts utilize a multi-tiered approach to measure ADAs and NAbs, and are experienced in the development and validation of qualitative and quasi-quantitative immunoassays. The first tiers are focused on detecting anti-drug antibodies (ADAs) that bind to the biologic drug. Samples are screened for the presence of antibodies, and antibody titer assessment followed by confirmation of the specificity of binding.
Immunogenicity assessment of NAb activity can be performed by utilizing cell based assay or competitive ligand binding assay (LBA). Cell-based neutralization assays are used to detect the presence of ADA which interferes with the biologic activity of the drug. Our Good Laboratory Practice (GLP) compliant immunogenicity laboratories are equipped with established industry immunoassay platforms such as ELISA, Radioimmunoassays (RIA), Electrochemiluminescence (ECL) and cell-based neutralization assays.

Immunogenicity Assessment Services:

  • Development and validation of qualitative and quasi-quantitative assays for total antibody (screen and titer) - includes confirmatory assay (specificity) along with statistical analysis by an in-house statistician
  • Multiple assay formats available: direct or bridging ELISA, direct or bridging ECL or RIA
  • Approaches to increase drug tolerance: MSD Bridging Mastermix with acid dissociation, ECL/ELISA based Solid phase extraction with acid dissociation (SPEAD), Affinity Capture Elution (ACE), “BEAD” (use of nanoparticles or magnetic beads) assays.
  • Development and validation of cell-based assays or receptor binding assays or competitive ligand binding assays for detection of neutralizing antibodies
  • Integration of pharmacokinetic (PK) and immunogenicity results in animal and human studies

Expert immunogenicity Strategy, Design and Implementation
With Intertek, you gain a partner with extensive experience and knowledge in developing immunogenicity programs. Each project presents its own unique challenges, and so our Principal Investigators will work closely with you to ensure that regulatory requirements for a validated assay are met. Through efficient management and proactive communication, we will help you to meet all immunogenicity testing requirements over your product’s development lifecycle.

Related Service:

Bioanalysis Services 

Need help or have a question? +1 800 967 5352

Need help or have a question?

+1 800 967 5352
+44 161 721 5247