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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.

In-Process Analytics

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

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Bioassay Development

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

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Product Characterization

  • Glycan profiling
  • Structural characterization
  • Thermal analysis

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Stability Analysis

  • Short and long term analysis
  • Accelerated stability analysis

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