Evaluating Purity in Therapeutic Protein Production
The purity of a protein-based drug, such as a monoclonal antibody (mAb), must be measured during the manufacturing process, and prior to its administration to patients. Purity refers to relative freedom from variants and extraneous matter. This interactive scrollable explains why purity is an important attribute of drug development, describes the different types of mAb variants, and provides an overview of the analytical techniques that can be used to screen for various types of mAb variants.
Topics
- ALXCollab
- acidic mAb
- analytical method
- attribute science
- basic mAb
- biologic
- capillary electrophoresis sodium dodecyl sulfate
- CE-SDS
- charge variant
- disulfide bond variant
- drug efficacy
- drug immunogenicity
- drug potency
- drug product
- drug purity
- drug safety
- glycosylation
- heavy chain
- IEX
- ion exchange chromatography
- LC-MS-MS
- LC-MS
- light chain
- liquid chromatography coupled with tandem mass spectrometry
- liquid chromatography-mass spectrometry
- mAb aggregate
- mAb fragment
- mAb structure
- mAb variant
- mAb
- monoclonal antibody structure
- monoclonal antibody variant
- monoclonal antibody
- oxidation
- post-translational modification
- process development
- PTM variant
- PTM
- purity testing
- purity
- SEC
- size exclusion chromatography
- size variant
- therapeutic protein