SIAT^® Tissue Damage Study Service

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It has been reported that any of drugs have the potential to induce tissue damage which can driver an immune response. Hence, it is necessary to assess the tissue damage induced by a drug during an immunogenicity test for a drug candidate. Creative Biolabs has accumulated a lot of experience in a drug's immunogenicity assay. We are committed to offering the best tissue damage research services to help you obtain the immunological data related to drug candidates.

Introduction of Tissue Damage

Tissue damage includes injury to the muscles, bones, tendons, ligaments, cartilage, and skin. It is caused by many unexpected events that may disrupt the homeostasis of the body causing cell damage, such as traumatic events, chemicals, infections, arthritis, and immunological factors. A number of reports have been suggested that a number of drugs have the potential to cause damage. For example, the statin class of drugs, such as Bayol (also known as cerivastatin), may cause damage to a patient's muscles. Statin-induced tissue damage can also lead to arrhythmia, heart failure, kidney failure, and even death. Besides, an antibiotic prescribed to treat an upper respiratory infection may lead to tendon ruptures and permanent disabilities. Drug-induced damage to non-target tissue can produce an immune response, further resulted in an inflammatory response. Therefore, it is not enough to test the immunogenicity of the drug itself, and the test should also include the effect of the drug on tissue damage or immune system.

Fig.1 The initiation and progression events relevant to idiosyncratic drug-induced liver injury. (Chen, 2016)

Tissue Damage Study

The aim of tissue damage is to determine the damage of a drug to non-target tissue, to predict the possible secondary diseases induced by a drug, and to better understand the potential immunogenicity or cytotoxicity to non-target tissue. The tissue damage study should include:

Construction in vitro cell systems simulating drug-targeting human tissues
In vitro evaluation of the efficacy and safety of drug (such as cell viability assays)
Detection the tissue damage and immune response to non-target tissue (such as osmotic surveillance, mixed leukocyte reactions (MLR), microscopy-based histochemistry)
Detection of the changes of tissue microenvironment induced by-products of tissue damage (such as oxidative stress assay)

What Can We Do?

As a specialist in immunogenicity assay in a preclinical study, Creative Biolabs is confident in providing a wide range of immunogenicity assay services for various drug candidates, including the efficacy and safety of drugs. We have established a comprehensive technology platform that includes a variety of approaches for tissue damage study, such as succinate dehydrogenase activity (MTT assay), microscopy-based histochemistry, terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay, as well as oxidative stress assay. By MTT assay, we can assess cell metabolic activity. By TUNEL assay, we can detect apoptotic DNA fragmentation and thus identify and quantify apoptotic cells. Our professional scientists also customize an immunogenicity test protocol according to your special purpose.

If you have any problems, please don't hesitate to contact us for more details.

Reference

Chen, M. J.; et al. Drug-induced liver injury: Interactions between drug properties and host factors. Journal of Hepatology. 2016, 63(2): 503-514.

FAQ

What is tissue damage in the context of immunogenicity testing?
Tissue damage during immunogenicity testing refers to the harm that occurs in body tissues as a response to a drug candidate. This can result from direct cytotoxic effects of the drug or as an indirect consequence of the immune response triggered by the drug, such as inflammation or autoimmune reactions.
How does tissue damage affect immunogenicity testing outcomes?
Tissue damage can significantly impact the outcomes of immunogenicity testing by altering the immune system's response to the drug. Damage may promote the presentation of drug-related antigens to the immune system, potentially increasing the formation of anti-drug antibodies (ADAs), which can complicate the interpretation of immunogenicity results.
What mechanisms lead to tissue damage during drug testing?
Mechanisms that can lead to tissue damage during drug testing include direct toxicity of the drug to cells, immune-mediated damage where the immune system attacks cells perceiving them as foreign, and inflammatory responses that harm tissue structure and function. Each mechanism can vary based on the drug's chemical properties and the biological system's characteristics.
Can tissue damage be predicted during preclinical studies?
Tissue damage can sometimes be predicted during preclinical studies by examining the drug's mechanism of action, toxicity profiles in early experiments, and any previously known effects of similar compounds. Computational models and in vitro tests can also provide early warnings of potential cytotoxic effects.
What are common indicators of tissue damage in immunogenicity tests?
Common indicators include elevated levels of enzymes that signify cell death (such as liver enzymes), histopathological changes observed in tissue samples, and clinical signs such as inflammation, pain, or dysfunction in the affected organ systems. These indicators help assess the extent and nature of the damage.
What role do biomarkers play in detecting tissue damage during drug testing?
Biomarkers are crucial for detecting tissue damage during drug testing as they provide measurable indicators of biological or pathogenic processes. Common biomarkers include proteins or enzymes released by damaged cells, specific imaging findings, or changes in gene expression profiles that indicate stress or injury to tissues.