Immunogenicity testing

Wieslab have several years of experience within immunogenicity assessment of large molecules (Biologics and Biosimilars). We have access to a range of immunogenicity assays for detection and confirmation of Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) supporting nonclinical and clinical studies.
 

ADA and NAbs - Get the big picture

Our scientists are experienced in the development and validation of qualitative and semi-quantitative immunoassays.

A multi-tiered approach is used to measure ADAs and NAbs. During the first tiers, we focus on detecting anti-drug antibodies (ADAs) that bind to the biological drug. Samples are then screened for the presence of antibodies and any potentially ADA positive samples are retested for confirmation of the specificity of binding. For relevant cases, confirmed ADA positive samples will be titrated.

Our core technology iLite® for cell-based neutralizing antibody bioassays allows us to offer a full characterization of the ADA response to include testing for NAbs.

This thorough approach gives our clients a confirmed and documented approach to immunogenicity studies. 

We offer:

  • development and validation of qualitative and semi-quantitative assays
  • assay transfer
  • a range of different assay formats such as direct or bridging ELISA and MSD (with and with-out acid dissociation)
  • we have our own hot lab on site and can also offer in-house developed Radioimmunoassays (RIA).
  • assays that provide accurate results even when drug tolerance is developed
 
 
Bioanalytical-Knowledge