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