Accelerating drug development with rapid bioanalysis of compounds
Syngene offers best-in-class services for bioanalytical assay development, validation of critical small and large molecules and new chemical entities (NCEs), and early screening of compounds to expedite the drug development phase. Our robust, validated, highly sensitive, and selective bioanalytical methods help global clients quantitatively determine endogenous compounds. Our methods enable biomarker modulations in complex pre-clinical and clinical biological matrices such as plasma, serum, urine, tissue homogenates, and cerebral spinal fluids.
Syngene’s bioanalysis quantitation team holds a track record of effectively partnering on pharmaceutical or biotechnology research projects. Our experienced scientists continuously interact with customers, provide study updates, and maintain rapid turnaround times. We use tested systems and processes to maintain confidentiality and data integrity at every level. Our strict adherence to the guidelines issued by the US Food and Drug Administration (FDA), European Medicines Evaluation Agency (EMEA), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M10 draft help facilitate the timely completion of drug approval submissions.
We offer advanced bioanalytical method development and qualification as well as automated sample handling, with the team detecting and quantifying sensitive small molecules, and able to handle light-sensitive and cytotoxic compounds. Our experts have vast experience in conducting bioanalysis in multiple bio-matrices to support tissue distribution studies with cold compound, and cassette bioanalysis with 5 in 1 dosing for pharmacokinetic (PK) studies in mice and rats. Additionally, we also perform dried blood spot analysis, bioanalysis of chiral compounds, and pharmacodynamic (PD) biomarker testing.
Our experts use state-of-the-art and highly sensitive instrumentation such as AB Sciex QTRAP 5500+/4500, AB Sciex 6500+ with and without Selexion, AB Sciex HRMS-API 5600, and seven triple quadrupole systems (API-4500) with ultra-performance liquid chromatography (UPLC) as the front-end system. For the quantification of endogenous compounds, we employ light chromatography-mass spectrometry (LC-MS) based chemical derivatization approaches.