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001-es BibID:BIBFORM099689
035-os BibID:(Scopus)85116907972 (WOS)000706597500001
Első szerző:Kumar, Ramesh
Cím:Applications of capillary electrophoresis for biopharmaceutical product characterization / Kumar Ramesh, Guttman Andras, Rathore Anurag S.
Dátum:2022
ISSN:0173-0835 1522-2683
Megjegyzések:Capillary electrophoresis (CE), after being introduced several decades ago, has carved out a niche for itself in the field of analytical characterization of biopharmaceutical products. It does not only offer fast separation, high resolution in miniaturized format, but equally importantly represents an orthogonal separation mechanism to high-performance liquid chromatography. Therefore, it is not surprising that CE-based methods can be found in all major pharmacopoeias and are recommended for the analysis of biopharmaceutical products during process development, characterization, quality control, and release testing. Different separation formats of CE, such as capillary gel electrophoresis, capillary isoelectric focusing, and capillary zone electrophoresis are widely used for size and charge heterogeneity characterization as well as purity and stability testing of therapeutic proteins. Hyphenation of CE with MS is emerging as a promising bioanalytical tool to assess the primary structure of therapeutic proteins along with any impurities. In this review, we confer the latest developments in capillary electrophoresis, used for the characterization of critical quality attributes of biopharmaceutical products covering the past 6 years (2015? 2021).Monoclonal antibodies, due to their significant share in the market, have been given prioritized coverage.
Tárgyszavak:Orvostudományok Elméleti orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Biopharmaceuticals
Capillary electrophoresis
Critical quality attributes
Mass spectrometry
Monoclonal antibodies
Megjelenés:Electrophoresis. - 43 : 1-2 (2022), p. 143-166. -
További szerzők:Guttman András (1954-) (vegyészmérnök) Rathore, Anurag S.
Pályázati támogatás:BT/COE/34/SP15097/2015
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TKP2020-IKA-07
OTKA
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