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SIAT ® Ex Vivo Immunogenicity Assessment

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In silico immunogenicity assessment typically has some limitations because the prediction algorithms for most T cell receptor (TCR) epitopes are based on the analysis of the binding affinity and stability of human leukocyte antigen (HLA, also known as major histocompatibility complex, MHC) molecules to peptides. However, there are many other factors including protease cleavage sites within the antigen-presenting cells and T cell precursor frequency that all have certain impacts in defining the TCR epitopes. The binding affinity of HLA:peptide complex to TCR influences the immune response of an epitope as well. Therefore, further ex vivo immunogenicity assessment is needed to validate the results from in silico prediction.

Creative Biolabs offers the SIAT® ex vivo immunogenicity assessment service that utilizes human peripheral blood mononuclear cells (PBMCs) to provide a preview of immune response that closely resembles the immune response in vivo. The responses of human immune effector cells to candidate biotherapeutics are tested without the risks associated with first human dose. This ex vivo assessment provides a fast and cost-effective way to gain a full and first-hand understanding of the immunogenicity of your biotherapeutic drug candidates under the condition close to that in vivo. At the same time, it evaluates the overall developability for further advancement into animal models and clinical trials, as well as supports the regulatory filings for IND application.

A human dendritic cell (blue pseudo-color) in close interaction with a lymphocyte (yellow pseudo-color).
A human dendritic cell (blue pseudo-color) in close interaction with a lymphocyte (yellow pseudo-color).

Our platform sets the foundation of a comprehensive human blood bank from healthy donors, which represents different populations across the entire world. Multiple techniques such as ELISPOT, ELISA, and Flow Cytometry can be used. Our SIAT® ex vivo immunogenicity assessment service contains two major assays.

DC-T Cell Proliferation Assay
The SIAT® DC-T cell assay uses whole proteins to assess the factors that contribute to the immunogenicity. This ex vivo immunogenicity assessment can predict immunogenicity on a human population basis without the need of animal models. The released cytokines by T cells can be detected by Flow Cytometry or ELISPOT, the results of which are good indicators of T cell activation and proliferation status. Information provided by this assay instructs early development of biotherapeutic drug candidates in lead selection, humanization, and/or de-immunization. read more…

Antigen Presentation Assay
SIAT® antigen presentation assay is designed to evaluate antigen processing and presentation in vitro, which provides direct information for epitopes of an antigen that bind to HLA molecules and displayed to T cells by antigen-presenting cells. Our human blood cell bank covers all main human races. These HLA-typed cells can be used for customer's interests in specific research topic. The sequence information of T cell epitopes is analyzed by LC-MS/MS and other advanced techniques. read more…

More SIAT® Immunogenicity Related Services at Creative Biolabs
In Silico Immunogenicity Assessment
In Vitro Class II HLA Binding Assay
Ex Vivo Immunogenicity Assessment
    DC-T Cell Proliferation Assay
    Antigen Presentation Assay
In Vivo Immunogenicity Assessment
Anti-drug Antibodies (ADA) Assays
De-immunization Service


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