Conduct of Research
Toward Public Health & Safe Society
Immunogenicity Test
Immunotoxicology
Immunotoxicology is a study about abnormal symptoms of immune system and the mechanism generated when human is exposed to external substance, Immunotoxicology test investigates the abnormal symptom of immune system caused by drug, agricultural pesticide, general chemicals and environmental pollutants such as immunosuppression, abnormal improvement of immune function, immunogenicity, antigenicity, hypersensitiveness and autoimmunity.
Our immunotoxicology research started since 1994, which is one of the oldest laboratory in Korea among toxicology test institutes. To conduct flow cytometry, the most significant test in immunotoxicology test, we are equipped with latest devices including FACSCalibur introduced in 2009 for immune function and toxicology test, and we also conduct fundamental researches such as immunotoxicology mechanism research.
Drug toxicity test guideline published by EMEA in 2000 regulates the performance of immunotoxicology test on candidate substances that are observed with potential immunotoxicology from newly developed drug substances, and the guideline published by US FDA on October 2002 regulates the test condition and items specifically.
Field of Test
Bionalysis using ELISA
- We conduct bioanalytical method development, validation and sample analysis) by developing analysis method to quantify the biomarker of specimen or biomedicine. To identify if the analysis method is appropriate, we abide by the FDA and EMA guideline, and use the identified analysis method to quantify biomarker and biomedicine of specimen from TK, PK test and clinical test.
Immunogenicity Tests (Anti-Drug Antibody Assay and Neutralizing Antibody Assay)
- Immunogenicity is an important assessment item as it could cause safety issue in the process of drug development. It measures if anti-drug antibody is actually generated when the drug is injected, how much is the volume and whether it has neutralizing antibody.
Immunophenotyping Tests using Flow Cytometry
- Up to now, all immunotoxicology test guidelines takes it significant to measure the proportion of B-cell, T-cell, macrophage in blood cell orsplenocyte and observe the changes. For this, we conduct flow cytometry using fluorescent staining to distinguish the types of lymphocyte cell.
NK cell Tests
- HK cell is a cell that monitors to remove virus infected cell or tumour cell b circulating the body and compose a lymphocyte cell with T-cell, B-cell. HK cell test measures influence of drug on HK cell vitality to measure the vitality that removes cancer cells when drug injected splenocyte and blood cells from animal and cancer cells like YAC-1 cells are mixed.
Other Services
- We conduct tests such as lymphoproliferation on mitogen, mixed leukocyte response test, cytokine analysis test and various immnuoproliferation and autoimmune response, and immunity reinforcement function test on food and oriental medicine.
Related to Bioanalysis Department in charge : Bioanalytical and Immunoanalytical Research Group | Inquiry department : Industry Support Team | Tel : 042-610-8169, 042-610-8080
Related to ADA Department in charge : Bioanalytical and Immunoanalytical Research Group | Inquiry department : Industry Support Team | Tel : 042-610-8169, 042-610-8080