Immunogenicity testing

A multi-tiered approach

Assessment of drug immunogenicity (IMG) is a regulatory requirement and is considered part of the safety evaluation that all protein drugs undergo. With 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 pre-clinical and clinical studies.

We perform:

  • Measurement of immunogenicity (anti-drug antibodies and neutralizing antibodies) in healthy volunteers and patients for Biologics and Biosimilars
  • Pre-clinical evaluations to investigate drug exposure
  • Clinical evaluations to investigate unwanted immunogenicity and safety effects
  • We work on ELISA or Meso Scale Discovery (MSD) for ADAs. Reporter gene cell-based assays for applicable drugs for NAbs

ADA and NAbs

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.

Through the combined use of our extensive LBA immunogenicity knowledge and core technology iLite® for our cell-based Neutralizing Antibody bioassays, we can offer a full charactarization of NAbs.

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

Our immunogenicity services include:

  • 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

Anti-drug antibodies (ADAs)

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.

We work on ELISA or Meso Scale Discovery (MSD) for ADAs and always in a tiered approach.

An ADA assay consist of:

  • Screening assay
  • Confirmatory assay
  • Titer assay

Neutralizing antibodies (NAb)

We have access to a range of immunogenicity assays for detection of Neutralizing Antibodies (NAbs) supporting nonclinical and clinical studies.

We use both traditional Ligand biding Assays and state of the art Reporter gene cell-based assays (iLite).

A NAb assay consists of:

  • Single qualitative assay with positive/negative as outcome
  • Titer assay (occasionally)

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