Therapeutic proteins production and development process is often complex and requires using chemical substances to enhance protein expression and improve bioprocess. Due to their chemical nature, they usually interact with the target protein. Such substances are purified at later stages and consequently only small quantities and traces of them are present in the final drug product. Apart from process-related impurities, product-related impurities such as DNA, Host Cell Proteins, or truncated protein may appear and increase adverse effects risk, when administered in humans. Therefore, the use of robust and sensitive analytical methods and fine-tuning them in terms of matrix effect recovery is crucial to ensure safety. 

Selvita’s experience with product-related impurities:

  • DNA content
  • HCP

Selvita’s experience polymers:

  • Tween 20 HPLC CAD, HPLC-ELSD
  • Tween 80 HPLC CAD, HPLC-ELSD
  • Pluroni c F 68 HPLC CAD, HPLC-ELSD
  • Simethicone extraction, HPLC CAD, HPLC-ELSD

Selvita’s experience with other additives

  • Dithiothreitol (DTT), HPLC, oxidation
  • Trifluoroacetic acid (TFA), IC
  • Guanidinium chloride, HPLC
  • Antifoam 204, HPLC-CAD
  • Isopropylthio β galactoside (IPTG), HPLC-CAD
  • 2 deoxy 2 fluoro L fucose (2 DEF) LC-MS
  • Heavy metals and ions