Putting Science to Work

Exploratory/Discovery Toxicology

Syngene has proven experience to carry out a range of toxicology services to provide seamless integration between discovery and development programs.

General Toxicology

Study types include Dose-range finding studies, Repeat Dose toxicity studies of various duration and Toxicokinetic studies. In life phase of the Non-Rodent toxicology studies are done at the partner site (US, Canada or Europe).

Standard Species
  • Rat
  • Mouse
  • Rabbit
  • Guinea Pig
Routes of Administration
  • Oral (gavage, dietary, drinking water)
  • Intravenous Bolus and Infusion
  • Intramuscular
  • Intraperitoneal
  • Subcutaneous
  • Dermal, Ocular
Bio-potency Studies
  • Erythropoietin Potency Bio assays as per Pharmacopeia- EP and I/P
  • Bio identity and Bio assay in rabbits as per USP
  • FSH potency Assay- Rats as per USP, EP
  • Immunization studies in all species
Electronic Data Support
  • Xybion Pristima™ system for efficient, accurate data capture, entry, and reporting.
    • In-life
    • Clinical pathology
    • Necropsy
    • Histopathology
  • Full standard for the exchange of preclinical data (SEND) package production

We specialize in the development of bioanalytical methods to support Bioavailability and Pharmacokinetics studies. We provide both non-GLP and GLP bioanalytical services for both small and large molecules. The services include:

  • HPLC -UV and LC-MS/MS based methods and Elisa technology
  • Development of specialized Elisa Kits to meet project specific needs
  • Development of efficient extraction procedures (protein precipitation, liquid-liquid extraction, solid-phase extraction)
  • Development of analytical methods in the presence of different matrices (plasma, brain, liver, bile etc) and different species.
  • Immunogenicity and Neutralizing Antibody analysis.
  • Conducting toxicokinetics studies with a variety of animal models in a dedicated, quality-assured GLP environment.
  • Fully integrated bioanalytical analysis
  • Modeling services using the Phoenix WinNonlin® platform
Clinical Chemistry and Histopathology

Syngene has the state-of-the-art facility to provide a broad-based analysis of a variety of parameters in each of the following categories:

  • Hematology and coagulation analysis
  • Clinical chemistry analysis
  • Urinalysis
  • Gross pathology services
  • Histopathology services:
    • Routine and special histochemical staining
    • Primary pathology evaluation
    • Peer review
    • Immunohistochemistry techniques

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