Protein Analytics

For the demonstration and documentation of the batch-to-batch consitency of any given biopharmaceutical material, its identity, purity, quantity, bioactivity and profile of impurities must be confirmed. These tasks are addressed by our portfolio of analytical routine methods for quality control of biological APIs:

Identity Tests

  • Western blotting
  • SDS-PAGE
  • Isoelectric focusing
  • Peptide mapping
  • Amino acid analysis
  • Mass spectrometry
  • N-terminal sequencing

Purity Tests

  • HPLC (SEC, IEC, RP)
  • Capillary electrophoresis
  • Endotoxin content (LAL-test)
  • Host cell protein assay (Threshold? =>more info)
  • Host cell DNA assay (Threshold? => more info)
  • Bioburden
  • Virus testing
  • Residual solvents (GC)

Quantification Tests

  • Protein determination (Bradford, BCA)
  • UV/Vis spectroscopy
  • ELISA

Potency Tests

  • Bioactivity assays (=> more info)
  • Specific binding assays

General Tests

  • Appearance
  • pH
  • Osmolality
  • Ion chromatography

Under controlled conditions stability data can be generated as part of product relevant data according to the ICH guidelines.