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Please note that we are not a pharmacy or clinic, so we are unable to see patients and do not offer diagnostic and treatment services for individuals.


Immunogenicity and Immunotoxicity Evaluation

Immunogenicity and immunotoxicity are used to evaluate the influence of drug toxicity on the structure and function of the body's immune system and its mechanism of action. Our company has talented, highly trained toxicologists and a comprehensive technology platform focused on safety evaluation services. We provide end-to-end immunogenicity and immunotoxicity evaluation services to ensure that we can respond quickly to all the needs of rare disease research projects.

Introduction to Immunogenicity

Immunogenicity refers to the property of a drug to stimulate the body to form specific antibodies or sensitizing lymphocytes. Factors affecting immunogenicity mainly include molecular size, molecular structure, host, and foreignness, etc. Immunogenicity is a property of the drug itself, and the antibody response it induces can often affect the evaluation of drug toxicity. Mice, rats, guinea pigs, rabbits, and non-human primates are mainly used for immunogenicity evaluation.

Introduction to Immunotoxicity

Immunotoxicity evaluation includes immunosuppression, hypersensitivity, adverse immune stimulation, and autoimmunity, which may be related to pharmacological activity. Immunotoxicity evaluation is an important part of studying the effects of drugs or chemical substances on human health, for example, immunosuppression may lead to infection or reduced defense against tumors; immune enhancement may amplify autoimmune reactions or allergic reactions.

1-3-2-4 Immunogenicity and Immunotoxicity Evaluation-1 Fig.1 Immunotoxicity evaluation in biopharmaceutical development. (Subramanyam, M., et al., 2017)

Our Services

With extensive expertise in immunology and rich industry cooperation experience, our company's team of scientists tracks and guides immunogenicity and immunotoxicity evaluation services throughout the process.

Methods of Evaluation Drug Type of Evaluation Immunogenicity Evaluation Immunotoxicity Evaluation
  • Immunochemistry
  • Histopathology
  • Next generation sequencing
  • qPCR
  • Flow cytometry
  • Biomarker Analysis
  • Others
  • Antibodies
  • Recombinant cells
  • Antisense oligonucleotides
  • Peptides
  • Vaccines
  • Recombinant proteins
  • Others
  • Detection and characterization of anti-drug antibodies (ADAs)
  • Detection of neutralizing antibody
  • Cellular immune response assays
  • Confirmatory assays for ruling out false positive results
  • T-cell dependent antibody response (TDAR)
  • Tissue cross reactivity (TCR)
    White blood cell differential count
  • Globulin levels and A/G ratios
    Cytokine quantitation
  • Histopathological examination of lymphoid tissue, thymus and spleen
  • Hypersensitivity testing
  • Immunophenotyping testing
  • Natural killer cell activity assays
  • Cell Functional assays

Why Choose Us?

1-3-2-4 Immunogenicity and Immunotoxicity Evaluation-2
  • Fast and cost-efficient workflow
  • Cost-effective compared to other companies
  • Careful design and transparent operation process
  • High data quality and reliable analysis
  • Ph.D.-level scientists and skilled technicians
  • Exceptional post-sales support

Project Workflow

1-3-2-4 Immunogenicity and Immunotoxicity Evaluation-3

As an integrated CRO, our company has the capabilities and resources to provide professional communication and problem-solving support to ensure that we can quickly respond to the changing needs of your rare disease research projects. We provide comprehensive immunogenicity and immunotoxicity evaluation services to leading and emerging biopharmaceutical companies and scientific research institutions. If you are interested in our services, please feel free to contact us for more information.


  • Subramanyam, M., et al. "Translational challenges of immunotoxicity assessments." Current Opinion in Toxicology 4 (2017): 35-42.

All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.

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