Measurement of Sialic Acid Content Is Insufficient to Assess Bioactivity of Recombinant Human Erythropoietin-Reference-Cited by-同舟云学术

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Measurement of Sialic Acid Content Is Insufficient to Assess Bioactivity of Recombinant Human Erythropoietin

Published:2010 Issue:9 Volume:33 Page:1596-1599
ISSN:0918-6158
Container-title:Biological and Pharmaceutical Bulletin
language:en
Short-container-title:Biol. Pharm. Bull.

Author:

Yanagihara Shigehiro¹²,Taniguchi Yuya¹,Hosono Mareto¹,Yoshioka Eiji³,Ishikawa Rika⁴,Shimada Yoshihiro¹,Kadoya Toshihiko¹,Kutsukake Kazuhiro²

Affiliation:

1. Bio Process Research and Development Laboratories, Production Division, Kyowa Hakko Kirin Co., Ltd.

2. Graduate School of Natural Science and Technology, Okayama University

3. Pharmacokinetic Research Laboratories, Research Division, Kyowa Hakko Kirin Co., Ltd.

4. Takasaki Plant, Production Division, Kyowa Hakko Kirin Co., Ltd.

Publisher

Pharmaceutical Society of Japan

Subject

Pharmaceutical Science,Pharmacology,General Medicine

Link

http://www.jstage.jst.go.jp/article/bpb/33/9/33_9_1596/_pdf

Reference22 articles.

1. 1) ICH Guideline Q6B, Specifications: Test Procedures and Acceptance Oriteria for Biotechnological/Biological Products (1999).

2. HPLC as a replacement for the animal response assays for insulin

3. Liquid chromatographic control of the identity, purity and “potency” of biomolecules used as drugs

4. Prediction of thein vivoBiological Activity of Human Recombinant Follicle Stimulating Hormone Using Quantitative Isoelectric Focusing

5. Physicochemical Methods for Predicting the Biological Potency of Recombinant Follicle Stimulating Hormone: An International Collaborative Study of Isoelectric Focusing and Capillary Zone Electrophoresis

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1. Equivalence assessment of biotherapeutics with N- and O-glycosylation sites by sequential intact glycoform mass spectrometry (IGMS);Journal of Pharmaceutical and Biomedical Analysis;2023-09

2. UPLC-MS assessment on the structural similarity of recombinant human erythropoietin (rhEPO) analogues from manufacturers in China for attribute monitoring;Talanta;2020-12

3. Aggregate Forms of Recombinant Human Erythropoietin With Different Charge Profile Substantially Impact Biological Activities;Journal of Pharmaceutical Sciences;2020-01

4. Analysis of Three Epoetin Alpha Products by LC and LC-MS Indicates Differences in Glycosylation Critical Quality Attributes, Including Sialic Acid Content;Analytical Chemistry;2017-06-09

5. Evaluation of an In Vitro Cell Culture Assay for the Potency Assessment of Recombinant Human Erythropoietin;Alternatives to Laboratory Animals;2016-05

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