UPLC-MS assessment on the structural similarity of recombinant human erythropoietin (rhEPO) analogues from manufacturers in China for attribute monitoring
Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have e...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Alley, William [verfasserIn] |
|---|
| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2020transfer abstract |
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| Schlagwörter: |
Ultra-performance liquid chromatography High resolution mass spectrometry |
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| Übergeordnetes Werk: |
Enthalten in: Optical, water splitting and wettability of titanium nitride/titanium oxynitride bilayer films for hydrogen generation and solar cells applications - Mohamed, S.H. ELSEVIER, 2019, the international journal of pure and applied analytical chemistry, Amsterdam [u.a.] |
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| Übergeordnetes Werk: |
volume:220 ; year:2020 ; day:1 ; month:12 ; pages:0 |
| Links: |
|---|
| DOI / URN: |
10.1016/j.talanta.2020.121335 |
|---|
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ELV051410125 |
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| 245 | 1 | 0 | |a UPLC-MS assessment on the structural similarity of recombinant human erythropoietin (rhEPO) analogues from manufacturers in China for attribute monitoring |
| 264 | 1 | |c 2020transfer abstract | |
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| 520 | |a Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. | ||
| 520 | |a Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. | ||
| 650 | 7 | |a Glycan analysis |2 Elsevier | |
| 650 | 7 | |a Ultra-performance liquid chromatography |2 Elsevier | |
| 650 | 7 | |a High resolution mass spectrometry |2 Elsevier | |
| 650 | 7 | |a Intact mass analysis |2 Elsevier | |
| 650 | 7 | |a Biopharmaceutical characterization |2 Elsevier | |
| 650 | 7 | |a Recombinant EPO |2 Elsevier | |
| 650 | 7 | |a Peptide mapping |2 Elsevier | |
| 700 | 1 | |a Tao, Lei |4 oth | |
| 700 | 1 | |a Shion, Henry |4 oth | |
| 700 | 1 | |a Yu, Ying Qing |4 oth | |
| 700 | 1 | |a Rao, Chunming |4 oth | |
| 700 | 1 | |a Chen, Weibin |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |n Elsevier Science |a Mohamed, S.H. ELSEVIER |t Optical, water splitting and wettability of titanium nitride/titanium oxynitride bilayer films for hydrogen generation and solar cells applications |d 2019 |d the international journal of pure and applied analytical chemistry |g Amsterdam [u.a.] |w (DE-627)ELV003060667 |
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10.1016/j.talanta.2020.121335 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001983.pica (DE-627)ELV051410125 (ELSEVIER)S0039-9140(20)30626-3 DE-627 ger DE-627 rakwb eng 530 620 VZ 53.56 bkl Alley, William verfasserin aut UPLC-MS assessment on the structural similarity of recombinant human erythropoietin (rhEPO) analogues from manufacturers in China for attribute monitoring 2020transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. Glycan analysis Elsevier Ultra-performance liquid chromatography Elsevier High resolution mass spectrometry Elsevier Intact mass analysis Elsevier Biopharmaceutical characterization Elsevier Recombinant EPO Elsevier Peptide mapping Elsevier Tao, Lei oth Shion, Henry oth Yu, Ying Qing oth Rao, Chunming oth Chen, Weibin oth Enthalten in Elsevier Science Mohamed, S.H. ELSEVIER Optical, water splitting and wettability of titanium nitride/titanium oxynitride bilayer films for hydrogen generation and solar cells applications 2019 the international journal of pure and applied analytical chemistry Amsterdam [u.a.] (DE-627)ELV003060667 volume:220 year:2020 day:1 month:12 pages:0 https://doi.org/10.1016/j.talanta.2020.121335 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 53.56 Halbleitertechnologie VZ AR 220 2020 1 1201 0 |
| spelling |
10.1016/j.talanta.2020.121335 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001983.pica (DE-627)ELV051410125 (ELSEVIER)S0039-9140(20)30626-3 DE-627 ger DE-627 rakwb eng 530 620 VZ 53.56 bkl Alley, William verfasserin aut UPLC-MS assessment on the structural similarity of recombinant human erythropoietin (rhEPO) analogues from manufacturers in China for attribute monitoring 2020transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. Glycan analysis Elsevier Ultra-performance liquid chromatography Elsevier High resolution mass spectrometry Elsevier Intact mass analysis Elsevier Biopharmaceutical characterization Elsevier Recombinant EPO Elsevier Peptide mapping Elsevier Tao, Lei oth Shion, Henry oth Yu, Ying Qing oth Rao, Chunming oth Chen, Weibin oth Enthalten in Elsevier Science Mohamed, S.H. ELSEVIER Optical, water splitting and wettability of titanium nitride/titanium oxynitride bilayer films for hydrogen generation and solar cells applications 2019 the international journal of pure and applied analytical chemistry Amsterdam [u.a.] (DE-627)ELV003060667 volume:220 year:2020 day:1 month:12 pages:0 https://doi.org/10.1016/j.talanta.2020.121335 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 53.56 Halbleitertechnologie VZ AR 220 2020 1 1201 0 |
| allfields_unstemmed |
10.1016/j.talanta.2020.121335 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001983.pica (DE-627)ELV051410125 (ELSEVIER)S0039-9140(20)30626-3 DE-627 ger DE-627 rakwb eng 530 620 VZ 53.56 bkl Alley, William verfasserin aut UPLC-MS assessment on the structural similarity of recombinant human erythropoietin (rhEPO) analogues from manufacturers in China for attribute monitoring 2020transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. Glycan analysis Elsevier Ultra-performance liquid chromatography Elsevier High resolution mass spectrometry Elsevier Intact mass analysis Elsevier Biopharmaceutical characterization Elsevier Recombinant EPO Elsevier Peptide mapping Elsevier Tao, Lei oth Shion, Henry oth Yu, Ying Qing oth Rao, Chunming oth Chen, Weibin oth Enthalten in Elsevier Science Mohamed, S.H. ELSEVIER Optical, water splitting and wettability of titanium nitride/titanium oxynitride bilayer films for hydrogen generation and solar cells applications 2019 the international journal of pure and applied analytical chemistry Amsterdam [u.a.] (DE-627)ELV003060667 volume:220 year:2020 day:1 month:12 pages:0 https://doi.org/10.1016/j.talanta.2020.121335 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 53.56 Halbleitertechnologie VZ AR 220 2020 1 1201 0 |
| allfieldsGer |
10.1016/j.talanta.2020.121335 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001983.pica (DE-627)ELV051410125 (ELSEVIER)S0039-9140(20)30626-3 DE-627 ger DE-627 rakwb eng 530 620 VZ 53.56 bkl Alley, William verfasserin aut UPLC-MS assessment on the structural similarity of recombinant human erythropoietin (rhEPO) analogues from manufacturers in China for attribute monitoring 2020transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. Glycan analysis Elsevier Ultra-performance liquid chromatography Elsevier High resolution mass spectrometry Elsevier Intact mass analysis Elsevier Biopharmaceutical characterization Elsevier Recombinant EPO Elsevier Peptide mapping Elsevier Tao, Lei oth Shion, Henry oth Yu, Ying Qing oth Rao, Chunming oth Chen, Weibin oth Enthalten in Elsevier Science Mohamed, S.H. ELSEVIER Optical, water splitting and wettability of titanium nitride/titanium oxynitride bilayer films for hydrogen generation and solar cells applications 2019 the international journal of pure and applied analytical chemistry Amsterdam [u.a.] (DE-627)ELV003060667 volume:220 year:2020 day:1 month:12 pages:0 https://doi.org/10.1016/j.talanta.2020.121335 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 53.56 Halbleitertechnologie VZ AR 220 2020 1 1201 0 |
| allfieldsSound |
10.1016/j.talanta.2020.121335 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001983.pica (DE-627)ELV051410125 (ELSEVIER)S0039-9140(20)30626-3 DE-627 ger DE-627 rakwb eng 530 620 VZ 53.56 bkl Alley, William verfasserin aut UPLC-MS assessment on the structural similarity of recombinant human erythropoietin (rhEPO) analogues from manufacturers in China for attribute monitoring 2020transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. Glycan analysis Elsevier Ultra-performance liquid chromatography Elsevier High resolution mass spectrometry Elsevier Intact mass analysis Elsevier Biopharmaceutical characterization Elsevier Recombinant EPO Elsevier Peptide mapping Elsevier Tao, Lei oth Shion, Henry oth Yu, Ying Qing oth Rao, Chunming oth Chen, Weibin oth Enthalten in Elsevier Science Mohamed, S.H. ELSEVIER Optical, water splitting and wettability of titanium nitride/titanium oxynitride bilayer films for hydrogen generation and solar cells applications 2019 the international journal of pure and applied analytical chemistry Amsterdam [u.a.] (DE-627)ELV003060667 volume:220 year:2020 day:1 month:12 pages:0 https://doi.org/10.1016/j.talanta.2020.121335 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 53.56 Halbleitertechnologie VZ AR 220 2020 1 1201 0 |
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Enthalten in Optical, water splitting and wettability of titanium nitride/titanium oxynitride bilayer films for hydrogen generation and solar cells applications Amsterdam [u.a.] volume:220 year:2020 day:1 month:12 pages:0 |
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Enthalten in Optical, water splitting and wettability of titanium nitride/titanium oxynitride bilayer films for hydrogen generation and solar cells applications Amsterdam [u.a.] volume:220 year:2020 day:1 month:12 pages:0 |
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UPLC-MS assessment on the structural similarity of recombinant human erythropoietin (rhEPO) analogues from manufacturers in China for attribute monitoring |
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Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. |
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Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. |
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Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall glycosylation profiling, O-glycan profiling, and N-glycan mapping by UPLC-MS with an aim to develop an effective analytical methodology to monitor the product quality attributes of rhEPO analogues. Two rhEPO analogues manufactured in China were analyzed to demonstrate the principle of the developed methods. Each rhEPO product showed a characteristic glycoform profile with respect to the distribution of sialic acids across multi-antennary structures, the occurrence of O-glycosylation, O-acetylation on sialic acids, and the extension of N-glycan antennae with N-acetyllactosamine units. The study demonstrates that UPLC-MS is an effective analytical tool to characterize and monitor the glycosylation profiles among rhEPO analogues in order to detect and account for the divergence between rhEPO products, as well as the presence of unusual or unexpected glycans. |
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