Predictive Immunotoxicology

  • With the increasing number of biologics and immune targeting drugs in discovery and development, the need to be able to predict and measure potential immunotoxicological consequences for patients is becoming more and more important.
  • KWS BioTest specialises in mapping human immune function ex vivo in early development and as part of clinical trials, and can work with you to predict unexpected immunotoxicology and reduce the risks involved. 

How we can help

A key obstacle for the development of biological therapies, and drugs aimed at modifying the immune response, is the inherent risk of triggering adverse drug reactions in the patient. Such reactions may be a result of unexpected on-target effects or may be due to off-target effects such as Fc receptor binding or the development of anti-drug antibodies. The complexity of the interactions that drive immune responses make these effects difficult to predict, and yet the consequences for the patient when adverse reactions occur can be catastrophic, as has been clear from some recent trials.

In response to trials such as that with TGN1412, the FDA has now mandated PBMC cytokine release assays as part of the development process for antibody therapies. While useful, this cannot alone predict the range of potential immunotoxicological consequences of therapies, which involve diverse mechanisms as outlined in the diagram below.

Here at KWS BioTest we have validated primary human immunological assays that enable you to predict potential immunotoxicology during preclinical development, and can support your clinical trials to determine the mechanisms underlying any observed infusion reactions. By working with you and understanding your target, we can tailor a suite of assays to your needs.

Please get in touch with us to discuss how we can help you with your programme. 

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We use primary human immune cell assays to model the diverse immunological mechanisms that can drive immunotoxicological responses to novel therapeutics. 

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Our experience in working with the full range of human cell types enables us to select the right assays to test on-target effects on cytokine, chemokine and inflammatory mediator release.

In addition, our validated suite of assays using whole blood and PBMC, but also purified populations including T cells, dendritic cells, macrophages, platelets, and endothelial cells enables us to monitor Fc receptor interactions and functional alterations. 

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By selecting the right assays for the target and therapeutic type, KWS BioTest can reduce risks for your programmes and your patients.

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Novel biologics and immune modulating drugs can be benchmarked against a range of therapeutic antibodies with known toxicology profiles. 

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Our team of scientists are expert in providing support for projects spanning from early preclinical cell biology and in vivo efficacy models through to clinical trial sample analysis.

PD assays

• Ex vivo cell stimulation to assess activation, proliferation and cytokine/chemokine release

• Direct measurement of plasma/serum cytokine/chemokine panels

• Assessment of effects on leukocyte populations and subsets

• Analysis of target gene signature


Anti-drug antibody assays

• Primary assays for antibodies against therapeutic biologics

• Secondary assays to confirm specificity


Infusion-related reaction assays

• Cytokine release

• Complement activation, C3a, C5a, SC5b-9, CH50

• Specific IgE, Tryptase responses


Receptor occupancy analysis

• Receptor engagement and regulation of expression