Syngene’s Safety Assessment offers a full range of exploratory and GLP toxicology services supported by clinical and anatomic pathology services, formulation analysis, toxicokinetic analysis, and interpretation and reporting. General toxicology studies range from single-dose and repeat dose toxicology studies, genetic toxicology, juvenile toxicity and IND and NDA enabling safety toxicology package.
Syngene in the last few years itself (2015-2019) has executed over 170 acute tox studies, 70 repeat dose toxicology studies, 200 genetic toxicology studies (AMES, MNT and CA), and a couple of juvenile toxicology studies. We also have the capability and expertise to perform reproductive toxicology studies and chronic toxicology studies to support NDA. The Safety Assessment team has experienced and qualified scientists with 5 DABTs and 1 ACVP certified pathologists. Recently, Syngene’s pathologists have even been providing standalone histopathology and peer review services to companies: this has been a new addition to our service offerings. We have also successfully executed three (3) integrated IND+CMC packages for our partners in Europe for their regulatory filings. We have developed workflows that consistently deliver high quality data, with ‘first time right’ output, while maintaining industry-leading turnaround timelines. All rodent toxicology and safety pharmacology (Irwin test and respiratory functions) for the IND package are conducted in-house at Syngene. We deliver on the higher species of the IND packages by having the in-life portion of non-rodent toxicology studies, executed at one of our strategic partners, while the bioanalysis, toxicokinetics analysis and histopathology of non-rodent studies are done in-house at Syngene. The IND toxicology packages at Syngene have been completed and delivered within 26 weeks (~6 months) with this seamless and strategic collaboration.
Central to our ability to deliver world-class toxicology services to our global clients is our state-of-the-art vivarium for conducting toxicology studies in rodents. Our facility is AAALAC accredited and GLP certified since 2009. The facility has sufficient capacity to undertake genetic toxicology and GLP toxicology studies. Since most of our clients and some of our third-party vendors are based in US and Europe, we have developed effective work patterns and processes and robust communication systems that keep us connected and ensure high quality, and timely communication across time zones while maintaining the security of the data being shared. The data are shared electronically with the client through a secure portal; proprietary histopathology software for sharing electronic images with the client pathologists (Spectral Insights, India) for immediate review of the key findings, preclinical data capture software and data submission to FDA in SEND format (Pristima and Savante from Xybion Corporation) are some of the key examples.