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