All Services at a Glance

HERE ARE OUR PRODUCTS AND SERVICES. IF YOU ARE INTERESTED IN MORE INFORMATION PLEASE FEEL FREE TO GET IN TOUCH WITH US.

General toxicology

  • Dose range-finding studies
  • Single dose toxicity studies / Extended single dose toxicity studies
  • Repeated dose (subchronic/chronic) toxicity studies
  • Local tolerance testing (in vivo)
  • Target animal safety studies
  • Phototoxicity testing

In vitro toxicology

  • Bacterial reverse mutation test (Ames test)
  • MTT/XTT cytotoxicity assay
  • In vitro micronucleus test
  • Mammalian erythrocyte (in vivo) micronucleus test
  • Mouse Lymphoma Assay (MLA)

Safety pharmacology

  • Safety pharmacology core battery within repeated dose toxicity: nervous system, cardiovascular system, respiratory system
  • Standalone Irwin test
  • Standalone plethysmography test
  • Standalone telemetry study (in cooperation with external partner)
  • hERG channel assay (in cooperation with external partner)

Irritation and Delayed-type Hypersensitivity

  • Magnusson and Kligman Guinea pig maximization test (GPMT)
  • Local Lymph Node Assay (LLNA) with ELISA method in mouse
  • Intracutaneous reactivity in the rabbit
  • Skin irritation test in the rabbit (single and repeated exposure)
  • Acute skin irritation test in the rabbit
  • Acute eye irritation test in the rabbit
  • In chemico Direct Peptide Reactivity Assay (DPRA) test

Functional immunotoxicity

  • Immunotoxicological evaluation of toxicity studies
  • T-cell dependent antibody response (TDAR)
  • Natural killer cell (NK) activity assay
  • Cytotoxic T-cell (CTL) function assay
  • Macrophage/neutrophil function assay
  • T-cell proliferation assay
  • Immune cell phenotyping
  • Cytokine release assay
  • Complement activation assay
  • Complement-dependent cytotoxicity (CDC)
  • Acute phase protein measurements

Immunogenicity profiling

  • Anti-drug/target antigen antibody assay (ADA)
  • Cytokine/chemokine production
  • Immune cell phenotyping
  • Intracellular cytokine staining
  • Activation-induced surface markers
  • Immunohistochemistry of immune tissues

Batch release testing

  • In vitro potency assay of the infectivity of an oral vaccine
  • Determination of antibiotic residues in batch samples with ELISA

Other in vitro tests

  • Hemolysis assay
  • Coagulation assay
  • ELISA method transfer/development and validation
  • Immunohistochemical analysis
  • Tissue cross-reactivity (TCR) testing
  • In vitro phototoxicity test
  • In vitro skin irritation test
  • In vitro skin corrosion test
  • In vitro eye corrosion test
  • In vitro eye irritation test
  • In vitro skin sensitization U-SENS test
  • In vitro skin sensitization KeratinoSens test

Pharmacokinetic studies

  • Single and multiple dose pharmacokinetic studies
  • Bioequivalence studies in animals
  • Pharmacokinetic support for pharmacodynamic/toxicity studies
  • Bioavailability study
  • Calculation and evaluation of pharmacokinetic parameters (WinNonLin)

ADME

  • In vitro hepatocyte stability assay
  • In vitro metabolic stability in liver microsome fraction

Analytical activities

  • Bioanalytical method development
  • Bioanalytical method validation
  • Bioanalytical support for toxicokinetic studies
  • Bioanalytical support for clinical trials
  • Formulation analysis of dose formulations in toxicity studies
  • Formulation analytical method development
  • Formulation analytical method validation

Pharmacodynamics

  • Wound healing in minipigs
  • Glucose tolerance test
  • Receptor occupancy

Medical Devices

  • Cytotoxicity tests
    • MTT/XTT cytotoxicity assay (ISO 10993-5)
  • Genotoxicity tests
    • Bacterial reverse mutation test (Ames test) (ISO/TR 10993-33)
    • In vitro micronucleus test (ISO/TR 10993-33)
    • Mammalian erythrocyte micronucleus test (ISO/TR 10993-33)
  • Sensitization tests
    • Magnusson and Kligman maximization test (ISO 10993-10)
    • Local lymph node assay in the mouse (ISO 10993-10)
    • Closed Patch (Buehler) Sensitization test (ISO 10993-10)
  • Irritation tests
    • In vitro skin irritation with EpiDerm (ISO 10993-23)
    • Intracutaneous reactivity test (ISO 10993-23)
    • Primary skin irritation test (ISO 10993-23)
    • Primary ocular irritation test (ISO 10993-23)
    • Mucous membrane irritation tests (vaginal, rectal, penile etc) (ISO 10993-23)
  • Systemic toxicity tests
    • Material Mediated Pyrogenicity test according to US and European Pharmacopeia
    • Acute systemic toxicity test (dermal, intradermal, intramuscular, intraperitoneal, intravenous, oral, subcutaneous, dual route etc.) in rat or mouse (ISO 10993-11)
    • Repeated systemic toxicity test (subacute, subchronic and chronic, via all routes) in rat, mouse, rabbit, dog or minipig (ISO 10993-11)
  • Implantation tests
    • Test for subcutaneous implantation in mouse, rat, guinea pig or rabbit (ISO 10993-6)
    • Test for muscle implantation in rabbit (ISO 10993-6)
    • Test for bone implantation in mouse, rat, rabbit, dog or minipig (ISO 10993-6)

Other services

  • FACS
  • ELISA
  • HPLC-UV
  • LC/MS/MS
  • Clinical pathology (hematology, coagulation, clinical chemistry, urinalysis)
  • Histopathology
  • Providing blank samples for bioanalytical activity

For further information please feel free to start a conversation.