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.

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