SIAT®In VivoImmunogenicity Assessment

In vitroandex vivoassays are straightforward and able to provide a preview of the immunogenicity of biotherapeutic drug candidates. However, these assays also have some limitations. For instance, the frequency of antigen-specific T cells in naïve cell population derived from peripheral blood mononuclear cells (PBMCs) is quite low. Therefore, some positive response may be neglected. Moreover, various cell types, such as NK cells, NKT cells, CD4+and CD8+T cells, can secret many different cytokines, which interferes the measurement of cytokine production of a specific cell type, e.g.CD4+T cells. On the other hand, NK cells, CD8+T cells and other cell types play supportive roles in CD4+T cell activation. Thus, tuning the balance between removal of irrelevant responses and reservation of supportiveness for theex vivoculture becomes a major obstacle to more accurate assessments.

Diadigom of immuno reactions after therapeutic administration. (Lollini et al. 2006)Diadigom of immuno reactions after therapeutic administration. (Lolliniet al.2006)

vwinoffers one-stopin vivo免疫原性评估service taking advantages of our exclusiveSensitive Immunogenicity Assessment Technology® (SIAT®)platform. SIAT®in vivo免疫原性评估employs various animal models including HLA transgenic mice and humanized mice to deliver the most straightforward evaluation of both innate and adaptive human immune responses without putting patients at risk.

The use of normal mouse models to study the immunogenicity of biotherapeutic drugs is flawed. Biotherapeutic drugs that are non-immunogenic in human may be foreign to mice and therefore elicit immune responses in mice. In collaboration with partners,vwinhas developed several enhanced mouse models to conductin vivo免疫原性评估. The featured mouse models are described below.

HLA transgenic mice
Specific human HLA genes are incorporated into HLA class II-deficient mice to construct a mouse model that expresses human HLA II molecules other than mouse ones. These mice are able to process and present epitopes in complex with human HLA II and subsequently activate the epitope-specific T cells. This kind of mouse model is of great help in evaluating, predicting, and comparing the immunogenicity of structural similar biotherapeutic drugs.

Humanized mouse models
In the HLA transgenic mice, antigens are presented with human HLA molecules to mouse TCR, which confines the usage of HLA transgenic mice for testing the immunogenicity of a human biotherapeutic drug candidate. Therefore, humanized mouse models have been developed to improve this situation. Immunodeficient SCID-SID-NSG mice are engrafted with functional human hematopoietic stem cells (CD34+), liver and/or thymus so that a functional human immune system is reconstructed. This kind of humanized mouse models can be used to study the immunogenicity of biotherapeutic drugs in a full human immune system.

SIAT®in vivo免疫原性评估service provides versatile assays for the investigation of immunogenicity of novel candidate drugs, such as local lymph node assay, hypersensitivity response measurement, and cutaneous anaphylaxis assays. Our service will help to accelerate the development of your novel drug candidates by systematically addressing the evaluation of immunogenicity, which promises a clear vision and guideline before entering clinical trials.


  1. Lollini, Pier-Luigi, et al. "Vaccines for tumour prevention."Nature Reviews Cancer6.3(2006): 204 - 216。

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

All listed services and products are For Research Use Only. Do Not use in any diagnostic or therapeutic applications.

Online Inquiry


Call us at:
Our customer service representatives are available 24 hours a day, 7 days a week.Contact Us