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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 Egyéb TKP2020-IKA-07 OTKA
Internet cím:	Szerző által megadott URL DOI Intézményi repozitóriumban (DEA) tárolt változat
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001-es BibID:	BIBFORM115946
035-os BibID:	(cikkazonosító)117397 (scopus)85175539890
Első szerző:	Rathore, Anurag S.
Cím:	Recent progress in high-throughput and automated characterization of N-glycans in monoclonal antibodies / Rathore Anurag S., Guttman Andras, Shrivastava Anuj, Joshi Srishti
Dátum:	2023
ISSN:	0165-9936
Megjegyzések:	N-glycosylation of monoclonal antibody therapeutics is a post-translation modification and a critical quality attribute because of its significant impact on the bioavailability as well as the efficacy of these products. The structural complexity and heterogeneity of the asparagine linked oligosaccharides on monoclonal antibodies present a challenge towards their characterization. In order to control and monitor these N-glycosylations during commercial manufacturing of biotherapeutics, there is a continuous need for rapid, sensitive, robust, and affordable characterisation strategies. In this review, our primary focus is on recent advancements in high- throughput and automated techniques for sample preparation, data acquisition and analysis of monoclonal antibody N-glycans since 2015. This includes characterization at the intact glycoprotein, middle up, glycopeptide, and released glycan levels with the use of high-throughput and automated techniques. Bioinformatic tools have also been conferred including various databases, data analysis softwares, and computational tools for glycan structure builders.
Tárgyszavak:	Orvostudományok Elméleti orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk N-Glycosylation IgG Biosimilars Critical quality attributes Automation High throughput Bioinformatics
Megjelenés:	Trac-Trends In Analytical Chemistry. - 169 (2023), p. 1-19. -
További szerzők:	Guttman András (1954-) (vegyészmérnök) Shrivastava, Anuj Joshi, Srishti
Internet cím:	Szerző által megadott URL DOI Intézményi repozitóriumban (DEA) tárolt változat
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001-es BibID:	BIBFORM107301
035-os BibID:	(cikkazonosító)993262 (scopus)85140029635 (wos)000869088100001
Első szerző:	Rathore, Anurag S.
Cím:	Editorial : Characterization of biotherapeutic products / Rathore Anurag S., Smales C. Mark, Guttman Andras
Dátum:	2022
ISSN:	2296-4185
Tárgyszavak:	Orvostudományok Elméleti orvostudományok szerkesztőségi anyag folyóiratcikk
Megjelenés:	Frontiers in Bioengineering and Biotechnology. - 10 (2022), p. 1-3. -
További szerzők:	Smales, C. Mark Guttman András (1954-) (vegyészmérnök)
Internet cím:	Szerző által megadott URL DOI Intézményi repozitóriumban (DEA) tárolt változat
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001-es BibID:	BIBFORM106821
035-os BibID:	(cikkazonosító)339828 (scopus)85128474989 (wos)000804191600005
Első szerző:	Shrivastava, Anuj
Cím:	N-Glycosylation of monoclonal antibody therapeutics : A comprehensive review on significance and characterization / Shrivastava Anuj, Joshi Srishti, Guttman Andras, Rathore Anurag S.
Dátum:	2022
ISSN:	0003-2670
Megjegyzések:	N-glycosylation of therapeutic antibodies starts as a co-translational step followed by a set of post-translational modifications and is considered as one of the critical quality attributes because of its impact on biological functions as well as therapy outcome. In addition to detailed product characterization of these glycans by the manufacturers, their comprehensive analysis is also a regulatory requirement. However, the structural complexity and heterogeneity of these N-linked carbohydrates make their characterization quite challenging. In this review, we give a comprehensive overview of N-glycosylation diversity and its functional importance for monoclonal antibody therapeutic products. A descriptive coverage is also provided for the various strategies and techniques employed for oligosaccharide characterization, that include analysis of intact-glycoproteins, their sub-units, glycopeptides as well as released glycans through chromatographic, electrophoretic and spectroscopic techniques. To assist the readers, relevant examples from the literature are cited and critically discussed for each of the strategies and techniques. To conclude, a discussion on unique challenges associated with the analysis of this important post-translational modification is presented.
Tárgyszavak:	Orvostudományok Elméleti orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	Analytica Chimica Acta. - 1209 (2022), p. 1-18. -
További szerzők:	Joshi, Srishti Guttman András (1954-) (vegyészmérnök) Rathore, Anurag S.
Pályázati támogatás:	2018-2.1.17-TÉT-KR-201800010 Egyéb
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