Screening for Impurities in Therapeutic Protein Production

The relative concentration of various impurities must be measured during the manufacturing process for biologic drugs such as therapeutic proteins. An impurity in a drug product is any component other than the drug substance itself, or a component of its formulation. This interactive scrollable explains why therapeutic proteins must be tested for impurities, describes the types of impurities that are tested for in the manufacturing of a therapeutic protein, and provides an overview of the analytical techniques that can be used to screen for various impurities.

Topics

  • ALXCollab
  • affinity chromatography
  • analytical method
  • attribute science
  • biologic
  • cell-based impurity
  • drug product
  • ELISA
  • engineered cells
  • enzyme-linked immunosorbent assay
  • HCP
  • host cell DNA
  • host cell protein
  • impurity
  • LC-MS
  • liquid chromatography-mass spectrometry
  • mAb
  • monoclonal antibody
  • potential safety concern
  • process development
  • process-related impurity
  • Protein A affinity chromatography
  • Protein A
  • protein purification
  • purification
  • qPCR
  • quantitative polymerase chain reaction
  • therapeutic protein