Protein Characterization

Solvias can comprehensively characterize any protein biopharmaceuticals for the chemistry manufacturing and controls (CMC) part of regulatory submissions for the approval of clinical trials, and the authorization to market a new drug. Typically, these characteristics include:

Quantity

  • UV absorbance A280
  • Quantitative amino acid analysis
  • Nitrogen determination
  • Protein assay (Lowry)
  • Immunoassay (ELISA)

Physico-chemical Properties

  • Molecular weight
  • Isoform pattern and isoelectric point
  • Extinction coefficient
  • Electrophoretic and chromatographic patterns
  • Spectral properties

Structural Characterization

  • Amino-acid composition
  • Amino-acid sequence
  • Terminal amino acids
  • Peptide mapping
  • Sulfhydryl groups and disulfide bridges
  • Carbohydrate structure and monosaccharide composition

Our Comprehensive Set of Analytical Methods for the Characterization of Biologics Includes:

  • Separation science: CE, SEC, HPLC, HPAEC-PAD, slab gel electrophoresis
    Capillary electrophoresis: CGE, CIEF, CZE, iCE280
  • Physical methods, analytical ultracentrifugation, spectroscopy CD, UV, FL, IR
  • Mass spectrometry, MALDI TOF-TOF
  • LC-MS/MS (iontrap)
  • Immunological methods, ELISA, western blotting, threshold analysis,
  • Complex structural elucidation, carbohydrate characterization, PEGylated proteins, peptide mapping

Access to Solvias’ scientific experience and state-of-the art technology platforms provides you with an understanding of the complexity of any biologic, an essential step in drug development.