Detection and quantitation of process-related impurities in biopharma manufacturing
Learn the challenges in the detection and quantitation of process-related impurities, including nitrosamine and azido impurities, and Syngene’s capabilities and solutions to resolve them.
Holistic, mechanism-driven approach to toxicity assessment using Computational and Data Sciences
Learn how Syngene provides in silico and in vitro support for holistic toxicity assessment using Computational & Data Sciences.
Small Molecule Development and Manufacturing
Syngene’s offers an end-to-end platform to deliver integrated and standalone services for small molecules across the Development continuum.
Characterization of acquired resistance mutations to menin inhibitors
Publication: American Association for Cancer Research
LP-07 In silico analysis using Derek and Sarah along with ICH M7 expert review accurately predicts Mutagenicity and Carcinogenicity of Nitrosamines
Publication: Toxicology Letters
Challenges in setting permitted daily exposure limits for pharmaceuticals: A review
Publication: National Library of Medicine; International Journal of Risk & Safety in Medicine
Approaches for setting occupational exposure limits in the pharmaceutical industry
Publication: Journal of Applied Toxicology Wiley
Predicting genotoxicity and carcinogenicity of drugs and chemicals using using OECD QSAR, DEREK Nexus® and TEST
A comparison of in silico prediction of genotoxicity and carcinogenicity of drugs, with the results obtained from curated data in published literature.
How Syngene’s tech transfer approach helped a biotech company fast-track NDA approval for a novel compound to treat infections
Learn how Syngene ensured 100% first-time-right technology transfer for manufacturing limited number of batches of a novel compound to treat infections, including getting NDA approval in less than two years.
Regulatory role of Biophysics in Biologics CMC
Learn the role of biophysics-driven analytical tools in accurately identifying biologics CQAs and analyzing HOS to make the final product efficacious and safe for patients from a regulatory perspective.