Residual host cell protein from continuous cell lines - Effect on the safety of protein pharmaceuticals

被引：0
|
作者：
Lupker, JH [1 ]
机构：
[1] Sanofi Rech, Ctr Labege, F-31676 Labege, France
来源：
SAFETY OF BIOLOGICAL PRODUCTS PREPARED FROM MAMMALIAN CELL CULTURE | 1998年 / 93卷
关键词：
D O I：
暂无
中图分类号：
Q [生物科学];
学科分类号：
07 ; 0710 ; 09 ;
摘要：
The presence of residual host cell proteins in protein pharmaceuticals obtained from continuous mammalian cell lines has been a point of concern. Clinical experience with different biopharmaceuticals shows that residual protein in these highly purified products does not represent a danger to the health of the patients.
引用
收藏
页码：61 / 64
页数：4
相关论文
共 50 条
  • [1] Assessment of the immunogenicity of residual host cell protein impurities of OsrHSA
    Abiri, Naghmeh
    Pang, Jianlei
    Ou, Jiquan
    Shi, Bo
    Wang, Xianghong
    Zhang, Sucai
    Sun, Yunxia
    Yang, Daichang
    PLOS ONE, 2018, 13 (03):
  • [2] Residual on column host cell protein analysis during lifetime studies of protein A chromatography
    Lintern, Katherine
    Pathak, Mili
    Smales, C. Mark
    Howland, Kevin
    Rathore, Anurag
    Bracewell, Daniel G.
    JOURNAL OF CHROMATOGRAPHY A, 2016, 1461 : 70 - 77
  • [3] CHROMATOGRAPHIC ANALYSIS OF HOST-CELL PROTEIN IMPURITIES IN PHARMACEUTICALS DERIVED FROM RECOMBINANT-DNA
    OKEEFE, DO
    WILL, ML
    ACS SYMPOSIUM SERIES, 1992, 512 : 121 - 134
  • [4] Establishment and evaluation of detection methods for process-specific residual host cell protein and residual host cell DNA in biological preparation
    Tian, Yixiao
    Wang, Xinyue
    Shao, Dongyan
    Zhao, Wen
    Chen, Renan
    Huang, Qingsheng
    CELL BIOCHEMISTRY AND FUNCTION, 2024, 42 (02)
  • [5] Comparison of platform host cell protein ELISA to process-specific host cell protein ELISA
    Gunawan, Feny
    Nishihara, Julie
    Liu, Peter
    Sandoval, Wendy
    Vanderlaan, Marty
    Zhang, Heidi
    Krawitz, Denise
    BIOTECHNOLOGY AND BIOENGINEERING, 2018, 115 (02) : 382 - 389
  • [6] Mild hypothermic culture conditions affect residual host cell protein composition post-Protein A chromatography
    Goey, Cher Hui
    Bell, David
    Kontoravdi, Cleo
    MABS, 2018, 10 (03) : 476 - 487
  • [7] Cytoprotection following endoplasmic reticulum stress protein induction in continuous cell lines
    Bedard, K
    MacDonald, N
    Collins, J
    Cribb, A
    BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY, 2004, 94 (03) : 124 - 131
  • [8] Strategies for host cell protein analysis
    Hoffman, K
    BIOPHARM-THE APPLIED TECHNOLOGIES OF BIOPHARMACEUTICAL DEVELOPMENT, 2000, 13 (05): : 38 - +
  • [9] Host cell protein impurity analysis
    Hoffman K.
    Hoffman, Ken (ken@cygnustechnologies.com), 2018, Mary Ann Liebert Inc. (38): : 20 - 21
  • [10] Producing recombinant protein cell lines
    Fisch, I
    GENETIC ENGINEERING NEWS, 2004, 24 (20): : 54 - +
12345