Charge profiling and stability testing of biosimilar by capillary isoelectric focusing
© 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim..
CIEF was developed for the rapid analysis of charge heterogeneity of trastuzumab biosimilar using commercially available fluorocarbon-coated capillary. The CIEF master mix was composed of 0.30% w/v methyl cellulose, 2.3 M urea, 56.8 mM l-arginine, 1.52 mM iminodiacetic acid, 4.5% v/v carrier ampholytes (broad-range pI 3-10 and narrow-range pI 8-10.5 with ratio of 3:1), and 0.45% v/v 10.0, 9.5, 7.0, 5.5, 4.1 pI markers. To get a robust method to analyze charge heterogeneity, some separation parameters, including focusing time and separation temperature, were investigated and optimized. The optimized method gave good precision in estimated pI values of charge variants with RSDs of not more than 0.16% intraday analysis (n = 6) and < 0.18% interday analysis (n = 9). In addition, the applications of this method including purity, stability, lot consistency, peptide N-glycosidase F digest, and C-terminal lysine variants characterization were also investigated.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2014 |
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| Erschienen: |
2014 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:35 |
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| Enthalten in: |
Electrophoresis - 35(2014), 10 vom: 15. Mai, Seite 1461-8 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Cao, Junzi [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 28.12.2014 Date Revised 10.12.2019 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/elps.201300471 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM236220160 |
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| 245 | 1 | 0 | |a Charge profiling and stability testing of biosimilar by capillary isoelectric focusing |
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| 500 | |a Date Revised 10.12.2019 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim. | ||
| 520 | |a CIEF was developed for the rapid analysis of charge heterogeneity of trastuzumab biosimilar using commercially available fluorocarbon-coated capillary. The CIEF master mix was composed of 0.30% w/v methyl cellulose, 2.3 M urea, 56.8 mM l-arginine, 1.52 mM iminodiacetic acid, 4.5% v/v carrier ampholytes (broad-range pI 3-10 and narrow-range pI 8-10.5 with ratio of 3:1), and 0.45% v/v 10.0, 9.5, 7.0, 5.5, 4.1 pI markers. To get a robust method to analyze charge heterogeneity, some separation parameters, including focusing time and separation temperature, were investigated and optimized. The optimized method gave good precision in estimated pI values of charge variants with RSDs of not more than 0.16% intraday analysis (n = 6) and < 0.18% interday analysis (n = 9). In addition, the applications of this method including purity, stability, lot consistency, peptide N-glycosidase F digest, and C-terminal lysine variants characterization were also investigated | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Validation Study | |
| 650 | 4 | |a CIEF | |
| 650 | 4 | |a Charge heterogenity | |
| 650 | 4 | |a Monoclonal antibody | |
| 650 | 4 | |a Trastuzumab biosimilar | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 650 | 7 | |a Buffers |2 NLM | |
| 650 | 7 | |a Urea |2 NLM | |
| 650 | 7 | |a 8W8T17847W |2 NLM | |
| 650 | 7 | |a Methylcellulose |2 NLM | |
| 650 | 7 | |a 9004-67-5 |2 NLM | |
| 650 | 7 | |a Arginine |2 NLM | |
| 650 | 7 | |a 94ZLA3W45F |2 NLM | |
| 650 | 7 | |a Peptide-N4-(N-acetyl-beta-glucosaminyl) Asparagine Amidase |2 NLM | |
| 650 | 7 | |a EC 3.5.1.52 |2 NLM | |
| 650 | 7 | |a Trastuzumab |2 NLM | |
| 650 | 7 | |a P188ANX8CK |2 NLM | |
| 700 | 1 | |a Sun, Wen |e verfasserin |4 aut | |
| 700 | 1 | |a Gong, Feifei |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Wanhui |e verfasserin |4 aut | |
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