Syngene has proven experience to carry out a range of toxicology services to provide seamless integration between discovery and development programs.
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).
- Guinea Pig
Routes of Administration
- Oral (gavage, dietary, drinking water)
- Intravenous Bolus and Infusion
- Dermal, Ocular
- 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.
- Clinical pathology
- 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
- Gross pathology services
- Histopathology services:
- Routine and special histochemical staining
- Primary pathology evaluation
- Peer review
- Immunohistochemistry techniques