Analytical Development

 

The analytical lab is equipped with state-of-the-art instruments to provide analytical development & validation services catering to in-process, release testing and other requirements. We offer our experience in using high-end analytical tools and methods to characterize complex biologics. We have expertise in performing orthogonal analysis using various spectroscopic & spectrometric methodologies. The methods are developed in compliance with ICH, US FDA and EMA guidelines.

About analytical development
 
 
  • In-Process Analytics

  • HPLC/UPLC based methods
  • Process related impurity (HCP, HcDNA) analysis
  • Clone analysis through gel electrophoresis, western blot, biolayer interferometry, RTPCR
  • Bioassay Development

  • Mitogenic and Metabolic assays
  • Immunochemical assays
  • Cell based assays including ADCC, CDC
  • Product Characterization

  • Glycan profiling
  • Structural characterization
  • Thermal analysis
  • Stability Analysis

  • Short and long term analysis
  • Accelerated stability analysis
 
  • upstream development and scale up
  • upstream development and scale up
  • upstream development and scale up
Analytical Development