Nonclinical and Clinical Services

Nonclinical Studies

The Toxicological Science Division serves to perform nonclinical studies by taking full advantages of a vast array of techniques and renowned reliability that the former Mitsubishi Chemical Safety Institute Ltd. (MSI) had acquired through its broad range of accumulated experience.

Tests on Pharmaceuticals and Agrochemicals

Immunoassay Related Studies and In Vitro Bioassays

We perform concentration measurement of physiologically active substances such as hormones of various animal species by RIA and EIA. We regularly receive GLP inspections from the Pharmaceuticals and Medical Devices Agency, thus all of our tests and studies are compliant with GLP standards. Moreover, we have extensive background data including sex hormone cycle, intraday variation, and age-associated changes.
We evaluate pharmaceuticals in bioassays in vitro using samples such as cells, biological samples, and bacteria using highly advanced technology. We support our clients in elucidation of toxicity and efficacy of pharmaceuticals with a broad range of experience in biomarker measurement.

Hormone/Biomarker Assays

We perform concentration measurement of physiologically active substances such as hormones of various animal species by RIA and EIA.
We regularly receive GLP inspections from the Pharmaceuticals and Medical Devices Agency, thus all of our tests and studies are compliant with GLP standards.
Moreover, we have extensive background data including sex hormone cycle, intraday variation, and age-associated changes.

  • Measurement Available
    • Pituitary Hormones (ACTH, LH, FSH, GH, Prolactin, TSH, etc.)
    • Thyroid Hormones (T3, T4)
    • Adrenal Cortex Hormones (Cortisol, Corticosterone, Aldosterone, etc.)
    • Sex Hormones (Testosterone, Dihydrotestosterone, Estradiol, Progesterone, etc.)
    • Renal Function Markers (β2-Microglobulin, Albumin)
    • Inflammation/Tumor Markers (Cytokines, Eicosanoid, etc.)
    • Anemia/Hemorrhage Related Markers (Hemoglobin, Transferrin, Ferritin, etc.)
    • Others (Immunoglobulin, Blood Pressure/Cardiac Function Related Markers, etc.)

TK/PK Measurement by Immunoassay and Antibody Measurement

The immunoassay is generally used for determining the blood concentrations of biopharmaceuticals. Detection/Monitoring of antibodies to biopharmaceuticals administered in animals or humans is crucial. Our specialists are engaged in development of biopharmaceuticals with long-term experience in immunoassays and antibody measurement.

  • Development of Immunoassay Methods (ELISA, RIA)
  • Validation of TK/PK Measurement by Immunoassay, Sample Measurement (measurement compliant with GLP and reliability standards is available)
  • Measurement of Antibodies to Biopharmaceuticals (Measurement by ELISA, RIP, BIACORE System, Biological Activity Measurement)

Antibody Related Studies

We have rich experience in fields requiring advanced knowledge and skills, such as development of measurement systems using antibodies. Our immunoassay kits for experimental animals PanaTestR series are widely used in various research organizations including pharmaceutical companies.
Production of polyclonal antibodies and monoclonal antibodies is available in small quantities as well as bulk. We accept orders for purification/labeling of antibodies from milligrams to grams.
Moreover, affinity analyses of antibodies using BIACORE system and quantification of antibodies to biopharmaceuticals are also available upon request.

  • Preparation and Bulk Production of Antibodies
    • Monoclonal Antibodies (Immunoassays and Antibody Titer Assays, Cell Fusion/Cloning, Establishment of Hybridoma, Preparation of Culture Supernatants and Mouse Peritoneal Fluid, etc.)
    • Polyclonal Antibodies (Synthesis and Purification of Antigens for Immunoassays, Conjugation of Antibodies, Immunoassays and Antibody Titer Assays in Animals, etc.)
  • Purification, Modification, and Labeling of Antibodies
    • Purification (Protein A Measurement, Ammonium Sulfate Fractionation Measurement, Ion-Exchange Chromatography)
    • Preparation of Fragments (F(ab’)2, Fab’)
    • Labeling (HRP, ALP, Fluorescent Dye)
  • Preparation of Reagents for Experimental Animals (PanaTest®)
    • PanaTEST® Series
      Rat Prolactin, Albumin, CINC-1, α1-Acid Glycoprotein, β2-Microglobulin, Ferritin, Transferrin, Hemoglobin, etc.

In Vitro and Ex Vivo Tests with Biochemical Technology and Molecular Biotechnology

We support our clients for development, discovery, and quality control of pharmaceuticals, with our knowledge, experience, and technologies.

  • Cytotoxicity Tests of Medical Devices
  • In Vitro Anticancer Agent Screening
  • Expression Analyses of Specific Genes (Real-Time PCR)
  • Production of Transgenic Cells, In Vitro Drug Efficacy Evaluation in Cells with Forced Expression, Elucidation of Action Mechanism
  • Others (below is examples of tests available)
    • Measurement of Sterol Synthesis in Primary Cultured Rat Hepatocytes
    • Cytotoxicity Tests in Primary Hepatocytes and Adrenal Cortex Cells
    • Histamine Release Tests in Rat Intraperitoneal Mast Cells
    • Neutrophil Function Tests (Chemotaxis, Active Oxygen Production, Elastase Release)
  • Customized Tests upon Request of Clients
    • Studies on Effects of Drugs on the Endocrine System and Blood Hormone Concentrations
    • Receptor Binding Assays in Tissues of Animals Dosed with Drugs
    • Studies on Effects of Drugs on Thyroid Functions (Na[125I] Uptake and Organization in the Thyroid Gland)

All of our research and studies are in strict adherence to the laws concerning protection and management of animals with full respect of the standards concerning care and management of test animals, and have been accepted and certified for animal welfare practices.



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