Immunogenicity Assessment

Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. It may be wanted or unwanted:

• Wanted immunogenicity typically relates to vaccines, where the injection of an antigen (the vaccine) provokes an immune response against the pathogen, protecting the organism from future exposure. Immunogenicity is a central aspect of vaccine development.
• Unwanted immunogenicity is an immune response by an organism against a therapeutic antigen. This reaction leads to production of anti-drug-antibodies (ADAs), which affects pharmacokinetic parameters, deactivates the therapeutic effect, and may induce adverse reactions.

Unwanted immunogenicity can constitute a serious impediment to developing vaccines. In this context, immunogenicity assessment based on risk studies is crucial.

The general process of immunogenicity assessment

Immunogenicity of vaccine products is usually assessed using a stepwise approach (Figure 1). First, a screening assay is used to detect the presence of ADAs in treated patients. Confirmatory testing is subsequently performed to determine ADAs specificity for the vaccine and to eliminate false positives. For ADA-positive samples, characterization is performed to determine the titer and type of ADAs, and a bioassay or ligand binding assay is used to identify neutralizing antibodies. To evaluate the potential clinical impact of ADAs, immunogenicity assessments are conducted in conjunction with pharmacokinetic, safety, and efficacy assessments, with the totality of data considered.

Figure 1. Stepwise approach to assessing immunogenicity of vaccine products ^[1].

Our services

Alfa Chemistry has the ability to provide immunogenicity assessment services to our customers. We have developed a variety of techniques to screen for ADAs in vaccine products. These techniques include, but are not limited to the following.

Why choose us

By utilizing our experienced experts to work with your team, Alfa Chemistry helps you perform immunogenic assessments. If you have any questions related to immunogen assessment, please feel free to contact us. Alfa Chemistry is always your project partner.

Reference

1. Carlos, P.; et al. Assessing the immunogenicity of biopharmaceuticals. BioDrugs. 2016, 30: 195-206.

Our products and services are for research use only and cannot be used for any clinical purposes.

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Immunogenicity Assessment

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