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- Title
Size-Exclusion Chromatography for the Analysis of Complex and Novel Biotherapeutic Products.
- Authors
Rea, Jennifer; Fulchiron, David; Yun Lou; Darer, Luda
- Abstract
Recombinant biotherapeutics have been produced and marketed for several decades, providing life-changing medicines for a variety of indications. With the maturation of the biotherapeutic market over recent years, novel protein products such as conjugates, bispecifics, fusion proteins, and coformulations are being developed. The detailed characterization and quality control of complex biopharmaceuticals has proven to be more challenging than the typical two-light-chain/two-heavy-chain monoclonal antibody products. This study presents applications of size-exclusion chromatography (SEC) for characterization and quality control of novel biotherapeutic products, including antibody-drug conjugates, hydrophobic proteins, and coformulations. Examples of modifying SEC mobile-phase composition and running conditions to modulate the separation are discussed, as well as approaches and strategies for analyzing atypical protein products such as coformulations.
- Subjects
CHIMERIC proteins; ANTIBODY-drug conjugates; CHROMATOGRAPHIC analysis; QUALITY control; MANUFACTURED products; THERAPEUTIC equivalency in drugs; BIOPHARMACEUTICS
- Publication
LC-GC Europe, 2020, Vol 33, Issue 2, p87
- ISSN
1471-6577
- Publication type
Article