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Acceptable changes in quality attributes of glycosylated biopharmaceuticals.

作者信息

Schiestl Martin, Stangler Thomas, Torella Claudia, Cepeljnik Tadej, Toll Hansjörg, Grau Roger

出版信息

Nat Biotechnol. 2011 Apr;29(4):310-2. doi: 10.1038/nbt.1839.

DOI:10.1038/nbt.1839
PMID:21478841
Abstract
摘要

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Tumor necrosis factor antagonist mechanisms of action: a comprehensive review.肿瘤坏死因子拮抗剂的作用机制:全面综述
Pharmacol Ther. 2008 Feb;117(2):244-79. doi: 10.1016/j.pharmthera.2007.10.001. Epub 2007 Oct 26.
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Mechanisms of killing by anti-CD20 monoclonal antibodies.抗CD20单克隆抗体的杀伤机制。
Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase.
日本批准的生物类似单克隆抗体及其参照产品的特性分析,以揭示批准后阶段的质量特征。
BioDrugs. 2025 May 7. doi: 10.1007/s40259-025-00722-4.
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PET Imaging Expedites Detection of Aberration in the Humanization of an Annexin A1 Targeting Antibody.正电子发射断层扫描(PET)成像加速了膜联蛋白A1靶向抗体人源化过程中异常情况的检测。
Pharmaceuticals (Basel). 2025 Feb 21;18(3):295. doi: 10.3390/ph18030295.
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"Small is beautiful" - Examining reliable determination of low-abundant therapeutic antibody glycovariants.“小即美”——探讨低丰度治疗性抗体糖变体的可靠测定方法。
J Pharm Anal. 2024 Oct;14(10):100982. doi: 10.1016/j.jpha.2024.100982. Epub 2024 Apr 26.
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Soft-sensor model development for CHO growth/production, intracellular metabolite, and glycan predictions.用于预测中国仓鼠卵巢细胞生长/生产、细胞内代谢物和聚糖的软传感器模型开发。
Front Mol Biosci. 2024 Oct 22;11:1441885. doi: 10.3389/fmolb.2024.1441885. eCollection 2024.
7
Pregnancy-related changes in the canine serum N-glycosylation pattern studied by Rapifluor HILIC-UPLC-FLR-MS.基于 Rapifluor HILIC-UPLC-FLR-MS 研究犬血清 N-糖基化模式的妊娠相关变化。
Sci Rep. 2024 Sep 6;14(1):20861. doi: 10.1038/s41598-024-71352-z.
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Pharmaceuticals (Basel). 2023 Nov 2;16(11):1556. doi: 10.3390/ph16111556.
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Bioengineering (Basel). 2023 Sep 30;10(10):1149. doi: 10.3390/bioengineering10101149.
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Analysis of lysine clipping of a humanized Lewis-Y specific IgG antibody and its relation to Fc-mediated effector function.人源化Lewis-Y特异性IgG抗体的赖氨酸剪切分析及其与Fc介导的效应器功能的关系。
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