Exploratory/Discovery Toxicology

Unraveling the effect of dosages with precise analyses and expertise

Syngene’s toxicology services provide seamless integration between discovery and development programs. Our scientists have wide experience in exploratory and discovery toxicology, delivering consistent results according to client requirements.

Methodology

We conduct general toxicology studies, which include dose-range finding studies, varied duration repeat-dose toxicity studies, and toxicokinetic studies on species such as rats, mice, rabbits, and guinea pigs. Our routes of administration for test subjects include oral (gavage, dietary, drinking water), intravenous (bolus and infusion), intramuscular, intraperitoneal, subcutaneous, dermal, and ocular. We also conduct in-life phase toxicology studies on non-rodent species at partner sites located in the US, Canada or Europe.

Capabilities

Bio-potency studies

Our scientists conduct a range of bio-potency studies according to the pharmacopoeia of different countries. We follow the European pharmacopoeia (EP) and International pharmacopoeia (I/P) for erythropoietin potency bioassays, United States pharmacopoeia (USP) for bio-identity and bioassays in rabbits, and the EP and USP for follicle-stimulating hormone (FSH) potency assays in rats. We also perform immunization studies on all species.

Electronic data support

Our Xybion Pristima™ system, with its efficient and accurate data capture, helps with entry and reporting for in-life studies, clinical pathology, necropsy and histopathology. Our facilities follow the standard exchange of non-clinical data (SEND) format for storing and transfer of all preclinical data.

Bioanalytics

Our team of scientists has deep expertise in the development of bioanalytical methods that support bioavailability and pharmacokinetic studies. We provide the options of both good laboratory practice (GLP) standards and non-GLP standards for bioanalytical services in small and large molecules.

Using high-performance liquid chromatographic-ultraviolet (HPLC-UV) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) based methods, and enzyme-linked immunosorbent assay (ELISA) technology, our bioanalytical services include:

• Development of specialized ELISA Kits for project specific needs 
• Development of efficient extraction procedures such as protein precipitation, liquid-liquid extraction, solid-phase extraction
• Development of analytical methods for different species in the presence of different matrices such as plasma, brain, liver, bile, etc. 
• Analyses of immunogenicity and neutralizing antibodies

Toxicokinetics

We conduct toxicokinetics studies with a variety of animal models in a dedicated, quality-assured, good laboratory practice (GLP) environment. Equipped with a fully integrated bioanalytical analysis system, our laboratory provides modeling services using the Phoenix WinNonlin® platform.

Clinical chemistry and histopathology

Our state-of-the-art facilities to provide a wide range of analyses involving various parameters in each of the following categories:

• Hematology and coagulation analysis 
• Clinical chemistry analysis 
• Urinalysis 
• Gross pathology services 
• Histopathology services that include routine and special histochemical staining, primary pathology evaluation, peer review, and immunohistochemistry techniques