Products & Services / Bioanalysis

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We have the capabilities and the infrastructure at GVK BIO, to undertake medium to high throughput Bioanalysis for NCEs. We provide Bioanalytical services at fast turn-around-times by optimizing the methods and sample extraction procedures, for quantitative as well as qualitative analysis. The exposure of the test compounds in different biological matrices like Blood, Plasma, Serum, CSF and Tissue homogenates etc., is determined routinely at GVK BIO. We develop Novel Sensitive Methods for quantitation of Parent, Prodrugs, and Metabolites in biological matrices. We provide high throughput ADME sample preparation and analysis, using automated equipment to achieve ~1000 injections per day. We have implemented Watson LIMS Data Management System for early PK Studies.GVK BIO – Bioanalysis


Method Development for NCEs

  • Tuning, method development and data acquisition/processing driven through DQ
  • Pooling of compounds for LC optimization to increase efficiency
  • Elute using column (run time > 2min)/cartridge (Generic LC method with run time ~45 sec/sample)
  • Column switching technique for method development
  • Multiple column usage
  • Sample processing procedure – protein removal by precipitation, equilibrium dialysis and ultra-filtration, liquid-liquid extraction

Assay Criteria

  • Calibration curve (assay range)
  • Quality control
  • Matrix effects
  • Sensitivity (LOQ/LOD determination)
  • Recovery
  • Dilution QC
  • Variety of biological matrices like adrenal gland, blood, brain, heart, fat, lung, liver, lymph, kidney, salivary gland, pancreas, testis, muscle and spleen