Impact of cell culture on recombinant monoclonal antibody product heterogeneity

被引：38
|
作者：
Liu, Hongcheng [1 ]
Nowak, Christine [1 ]
Shao, Mei [2 ]
Ponniah, Gomathinayagam [1 ]
Neill, Alyssa [1 ]
机构：
[1] Alex Pharmaceut, Product Characterizat, Global Analyt & Pharmaceut Dev, CT06410, Manchester, Cheshire, England
[2] Alex Pharmaceut, Global Proc Dev, Late Stage Upstream Dev, CT06410, Manchester, Cheshire, England
来源：
BIOTECHNOLOGY PROGRESS | 2016年 / 32卷 / 05期
关键词：
cell culture; posttranslational modifications; recombinant monoclonal antibodies; N-LINKED GLYCOSYLATION; UNPAIRED CYSTEINE RESIDUES; DISULFIDE BOND REDUCTION; HAMSTER OVARY CELLS; HIGH-MANNOSE; MASS-SPECTROMETRY; CHARGE VARIANTS; EXCHANGE CHROMATOGRAPHY; TRISULFIDE MODIFICATION; ASPARAGINE DEAMIDATION;
D O I：
10.1002/btpr.2327
中图分类号：
Q81 [生物工程学（生物技术）]; Q93 [微生物学];
学科分类号：
071005 ; 0836 ; 090102 ; 100705 ;
摘要：
Recombinant monoclonal antibodies are commonly expressed in mammalian cell culture and purified by several steps of filtration and chromatography. The resulting high purity bulk drug substance still contains product variants differing in properties such as charge and size. Posttranslational modifications and degradations occurring during cell culture are the major sources of heterogeneity in bulk drug substance of recombinant monoclonal antibodies. The focus of the current review is the impact of cell culture conditions on the types and levels of various modifications and degradations of recombinant monoclonal antibodies. Understanding the relationship between cell culture and product variants can help to make consistently safe and efficacious products. (c) 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1103-1112, 2016
引用
收藏
页码：1103 / 1112
页数：10
相关论文
共 50 条
  • [21] PRODUCTION OF MONOCLONAL-ANTIBODY IN PLANT-CELL CULTURE
    GAO, J
    KONZEK, RL
    LINZMAIER, M
    BUCKLEY, KB
    MAGNUSON, NS
    REEVES, R
    AN, G
    LEE, JM
    ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 1993, 205 : 153 - BIOT
  • [22] Detection of Simkania negevensis in cell culture by using a monoclonal antibody
    Donati, Manuela
    Di Paolo, Maria
    Avanzi, Simone
    Di Francesco, Antonietta
    Fiani, Natascia
    Favaroni, Alison
    Caracciolo, Martina
    Cevenini, Roberto
    NEW MICROBIOLOGICA, 2013, 36 (01): : 85 - 88
  • [23] Defining Process Design Space for Monoclonal Antibody Cell Culture
    Abu-Absi, Susan Fugett
    Yang, LiYing
    Thompson, Patrick
    Jiang, Canping
    Kandula, Sunitha
    Schilling, Bernhard
    Shukla, Abhinav A.
    BIOTECHNOLOGY AND BIOENGINEERING, 2010, 106 (06) : 894 - 905
  • [24] Encapsulated animal cell culture for the production of monoclonal antibody (MAb)
    Kim S.-K.
    Son J.-H.
    Yu S.-H.
    Biotechnology and Bioprocess Engineering, 1997, 2 (2) : 73 - 76
  • [25] Evaluating the impact of media and feed combinations on CHO cell culture performance and monoclonal antibody (trastuzumab) production
    Gyorgypal, Aron
    Chaturvedi, Antash
    Chopda, Viki
    Zhang, Haoran
    Chundawat, Shishir P. S.
    CYTOTECHNOLOGY, 2025, 77 (01)
  • [26] Glutamine deamidation of a recombinant monoclonal antibody
    Liu, Hongcheng
    Gaza-Bulseco, Georgeen
    Chumsae, Chris
    RAPID COMMUNICATIONS IN MASS SPECTROMETRY, 2008, 22 (24) : 4081 - 4088
  • [27] Cell culture efforts to reduce glycation in recombinant humanized antibody
    Inn H Yuk
    Hung Huynh
    Kimberly Leach
    Amy Shen
    Boyan Zhang
    George Dutina
    Patrick McKay
    Amy Lim
    Brad Snedecor
    Microbial Cell Factories, 5 (Suppl 1)
  • [28] Analysis of monoclonal antibody product heterogeneity resulting from alternate cleavage sites of signal peptide
    Kotia, Ruchi B.
    Raghani, Anil R.
    ANALYTICAL BIOCHEMISTRY, 2010, 399 (02) : 190 - 195
  • [29] Application of calcium phosphate flocculation in high-density cell culture fluid with high product titer of monoclonal antibody
    Guoqiang Chen
    Zhiguo Su
    Feng Li
    Hui Fang Liu
    Bioprocess and Biosystems Engineering, 2017, 40 : 703 - 714
  • [30] Application of calcium phosphate flocculation in high-density cell culture fluid with high product titer of monoclonal antibody
    Chen, Guoqiang
    Su, Zhiguo
    Li, Feng
    Liu, Hui Fang
    BIOPROCESS AND BIOSYSTEMS ENGINEERING, 2017, 40 (05) : 703 - 714
12345