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Safety Assessment

Assessing the safety profile of new drugs through toxicity studies

Syngene’s safety assessment and toxicology services team offers a full range of exploratory and good laboratory practice (GLP) toxicology services that enable clients to assess the safety and toxicity profiles of new drugs. Our offerings are supported by clinical and anatomic pathology services, formulation analysis, toxicokinetic analysis, interpretation, and reporting services. 

Capabilities

Our general toxicology studies range from single-dose and repeat-dose toxicology studies, genetic toxicology, juvenile toxicity, to investigational new drug (IND) and new drug application (NDA) enabling safety toxicology packages. We also provide standalone histopathology and peer review services through our certified and experienced pathologists. 

The team expertly handles diverse routes of administration, such as oral, intramuscular, subcutaneous, interdermal, inhalation, intravitreal injection, and complex intravenous infusion studies. With streamlined workflows, processes, and robust communication systems, we ensure high-quality and timely communication across time zones.

Infrastructure & resources

Syngene provides world-class safety assessment and toxicology services through a state-of-the-art vivarium that is good laboratory practice (GLP) certified and accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). Spread across 54,000 square feet, the vivarium includes an animal holding space, housing several laboratory animals such as rats, mice, guinea pigs, and rabbits. The facility also includes a support space as well as dedicated areas for GLP and exploratory studies. 

The facility is fully equipped with top-of-the-line instruments for various kinds of studies: 

  • Pain and inflammation: Our equipment to study pain and inflammation includes UGO Basile’s plethysmometer, Hargreaves’ and von Frey apparatus, hot/ cold plates, and a tail-flick unit.
  • Hematology and biochemistry: We study blood diseases and biochemical processes using hematology analyzers such as Advia 2120i and Sysmex-XS 800i, and clinical chemistry analyzers such as Erba-EM 360 and Siemens Dimension Xpand Plus. Our teams are also equipped with CLINETEK Advantus urinary analyzer, Medica Easylyte electrolyte analyzer, and Start-4 coagulation analyzer. 
  • Histopathology: Our equipment to study tissues include automated vacuum tissue processors such as Leica’s ASP200 S and ASP300 S, Microm EC 350 embedding center, Microm HMS740 automated stainer, and a Leica CV5030 cover slipper. The lab is also equipped with microtomes such as Microm HM340E and HM355S with cryo console, hot plate, and water bath. Our microscopes include the Nikon 50i and ECi S fitted with Leica MC170 HD camera, and the Olympus BX53F, with microscope imaging software from Leica analysis suite bundle (Leica application suite).
  • Formulation analysis and bioanalytics: For quantitative measurements, we have a range of high-performance liquid chromatography (HPLC) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) instruments. The HPLC instruments include Agilent’s 1100 and 1200 series and Shimadzu’s Prominence UFLC series and Nexera UHPLC series. Our LC-MS/MS instruments include API 2000, 3200, 4000 (with Lightsight ™ software), and 4000 Q-Trap. We also use TurboVap instruments and a bullet blender for sample processing.
  • Miscellaneous: Our vivarium is equipped with EchoMRI and In-Vivo Xtreme imaging instruments as well as animal activity meters such as an Opto-Varimex-4 Auto-Track. Other miscellaneous equipment includes instruments from MagPIX, a small animal treadmill, and a grip strength meter.

Syngene also has a team of experienced and qualified scientists that includes eight pathologists certified as Diplomates of the American Board of Toxicology (DABT), one pathologist certified by the American College of Veterinary Pathologists (ACVP), and tenured study directors. Our low attrition rates enable us to provide continuous and high-quality client support. 

Reporting services

We deliver high-quality reports and provide a secure portal for electronic data transfer while maintaining industry-leading turnaround times. The team uses proprietary histopathology software such as Spectral Insights to share electronic images with the client’s pathologists enabling an immediate review of key findings. We also use online preclinical data capture software such as Xybion’s Pristima and Savante to submit data in SEND format to the Food and Drug Administration (FDA).

Safety Assessment and Toxicology Services at Syngene