IMMUNOGENICITY

Studies

At IBT, we specialize in immunogenicity testing studies in various animal models, including mice, rats, guinea pigs, and hamsters. Our team of experts has extensive experience in designing and conducting immunogenicity studies, ensuring adherence to regulatory guidelines and delivering high-quality data.

If you’re involved in the development of biologics, vaccines, or other therapeutic agents, immunogenicity testing in animal models is a crucial step to assess the immune response elicited by your product candidates. This page will provide you with valuable information about immunogenicity testing studies in commonly used animal models such as mice, rats, guinea pigs, and hamsters.

Immunogenicity testing studies in animals play a vital role in evaluating the safety and efficacy of biopharmaceutical products. These studies assess the immune response generated by the product and help researchers understand its potential immunogenicity, including the production of anti-drug antibodies (ADA) and their impact on therapeutic efficacy.

Here Are Some Key Considerations For Immunogenicity Testing Studies In Mice, Rats, Guinea Pigs, And Hamsters:

MOUSE

MOUSE

Mice are widely used in immunogenicity studies due to their well-characterized immune system and genetic resources. Different strains of mice, such as BALB/c, C57BL/6, and SCID mice, offer specific advantages depending on the research question. Mice provide a valuable platform for evaluating immunogenicity, generating antibodies, and studying immune responses against therapeutic agents.

RAT

RAT

Rats, particularly Sprague-Dawley and Wistar rats, are often utilized in immunogenicity studies. Rats offer advantages such as a larger size compared to mice, allowing for larger blood sample volumes, and a more similar immune system to humans in certain aspects. Rat models provide valuable insights into immunogenicity profiles and can complement studies conducted in mice.

GUINEA PIG

GUINEA PIG

Guinea pigs have a unique immune system and are commonly used in immunogenicity testing for vaccines and allergens. Guinea pigs can produce specific antibody responses, including IgG and IgE, which are crucial for evaluating immunogenicity and hypersensitivity reactions. They are particularly useful in studies related to respiratory allergens and adjuvanted vaccines.

HAMSTER

HAMSTER

Hamsters, such as the Syrian golden hamster, are utilized in immunogenicity testing studies for viral pathogens, vaccines, and antibody development. Hamsters offer advantages such as their susceptibility to specific viral infections, making them suitable for evaluating immune responses to viral antigens and viral vectors.

Hamsters, such as the Syrian golden hamster, are utilized in immunogenicity testing studies for viral pathogens, vaccines, and antibody development. Hamsters offer advantages such as their susceptibility to specific viral infections, making them suitable for evaluating immune responses to viral antigens and viral vectors.

When Conducting Immunogenicity Testing Studies In Animals, It Is Important To Consider The Following Factors

Animal Strain
Selection

Formulation And Treatment Route

Sample Collection Techniques

Endpoint Assays Specific To Target Products

Working with experienced researchers and following established protocols is crucial to obtain reliable and meaningful results.

To evaluate the antigen specific CD4 T cell responses to antigen, splenocytes from each mouse were isolated and stimulated in vitro with protein or cells alone as control and frequencies of IFN-γ, TNF-α and IL-2 producing CD4 and CD8+ memory (CD44hiCD62Llo) T cells were studied for the responses using intracellular cytokine staining and analyzed by flow cytometry.

To evaluate the antigen specific CD4 T cell responses to antigen, splenocytes from each mouse were isolated and stimulated in vitro with protein or cells alone as control and frequencies of IFN-γ, TNF-α and IL-2 producing CD4 and CD8+ memory (CD44hiCD62Llo) T cells were studied for the responses using intracellular cytokine staining and analyzed by flow cytometry.

Vaccine Candidates Tested: