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IMMUNOGENICITY: Screening for ADA & NAbs

Securing a safe and efficient drug by determining and assessing undesirable immunogenicity effects.

There is a steady rise in the number of proteins being approved for use as therapeutic agents with major therapeutic gains and upsides, but besides the huge benefits that come with the use of these biologics, there is one major limitation that arises when using these therapeutics – formation of anti-drug antibodies (ADAs) and Neutralizing antibodies (Nabs).

The complex nature of these therapeutics and their interactions with various endogenous proteins in the human body give them unique pharmacokinetic and pharmacodynamic (PK/PD) properties and can induce anti-drug antibodies (ADA), some of which act to neutralize the effect of the drug (NAbs). The assessment of such undesirable immunogenicity effects is a key element in biological drug development.

Assessing undesirable immunogenicity effects is key

What are Neutralizing Antibodies?

A neutralizing antibody (NAb) is an antibody that is responsible for defending cells from pathogens and are produced naturally by the body as part of its immune response. Their production is triggered by both infections and vaccinations against infections. In an immunogenetic context it will bind to a drug and neutralize its therapeutic effect. 

Immunogenicity effects
A potential provocation of the body’s own immune system

Immunogenicity is the ability of therapeutic proteins to provoke such an antibody response, since they contain unique sequences that can elicit an immune response. Since biologics are proteins, they can be recognized by the immune system as foreign molecules, and so the body can mount an immune response against them in the form of ADAs. 

Some ADAs (NAbs) neutralize the biological drugs and decrease the drug’s efficacy and increase its clearance, resulting in patient secondary unresponsiveness, leading to worsening of their disease.

Today, authorities require estimations of immunogenicity in the clinical trial programs (Phase I through Phase IV) for new biological drugs (EMA 2007 and 2012 and the FDA draft 2009). According to EMA and FDA, tests for neutralizing anti-drug antibodies (NAbs) with a biological activity assay should be included where it is relevant.



Svar offer a multi-tiered approach in compliance with regulatory Guideline for detection and confirmation of Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs). With several years of experience within immunogenicity assessment of large molecules (Biologics and Biosimilars), we have experience in supporting pre-clinical and clinical studies, both assessed by a regular ligand binding assay and by detection of NAbs in a functional cell-based assay, and therefore have access to and experience of a range of immunogenicity assays

Our competencies are leveraged in the following solutions:

  • Multi-tiered approach in compliance with regulatory Guidelines
  • Support in pre-clinical and clinical studies
  • Detection and confirmation of Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
  • Assessment by regular ligand binding assays and detection of NAbs on a functional cell-based assay
Partner up with us and we'll help you secure a safe and efficient drug by determine and assessing undesirable immunogenicity effects before they happen.

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Immunogenicity, ADA and NAbs

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