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Immunogenicity Testing


Immunogenicity Testing:
Gene therapy, tumor vaccines, and other emerging treatment options require immunogenicity testing of the vectors. Immunogenicity testing needs to assess both T cell responses and B cell responses.Model CreationUsing immunocompetent mice for immunization, T cell activation is detected through flow cytometry and Elispot methods. B cell antibody production is then detected through flow cytometry or ELISA methods, thereby confirming the immunogenicity of the test product.
Testing Content:

T cell response: Experiments are conducted using an immunocompetent mouse model, employing flow cytometry and Elispot methods to evaluate T cell activation. Assess whether the test product can stimulate a specific T cell response.
B cell response: Specific antibodies produced by B cells are detected through flow cytometry or ELISA methods. Detect the generation of specific antibodies induced by the test product.
Cytokine secretion: Assess the secretion of cytokines (such as IFN-γ, IL-4, etc.) in response to stimulation by the test substance to evaluate the Th1/Th2 immune response type.
Formation of memory immune cells: Assess whether the test product can induce long-term immune memory. T cell immune response.

Immunogenicity testing is applicable to:
Gene therapy drugs
Vaccines
Vectors
Biological drugs