Process analytics for purification of monoclonal antibodies

被引：59
|
作者：
Flatman, Stephen [1 ]
Alam, Imtiaz [1 ]
Gerard, Jeffery [1 ]
Mussa, Nesredin [1 ]
机构：
[1] Lonza Biol Plc, Slough SL1 4DX, Berks, England
来源：
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES | 2007年 / 848卷 / 01期
关键词：
antibodies; purification; analytical methods; process analytical technology;
D O I：
10.1016/j.jchromb.2006.11.018
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
The application of appropriate analytical methods is an essential requirement for the purification of therapeutic antibodies. A range of analytical methods need to be employed to effectively determine the purity, identity, integrity and activity of these important class of pharmaceuticals. These include notably electrophoresis, high performance liquid chromatography and immunoassays. Regulatory and industry demands in recent years have brought the need for improvements and many have been successfully implemented. This article reviews the current analytical methods applied to support the purification of monoclonal antibodies. (c) 2006 Elsevier B.V. All rights reserved.
引用
收藏
页码：79 / 87
页数：9
相关论文
共 50 条
  • [41] The application of monoclonal antibodies to the immunoaffinity purification of human ferritin
    Zhang, DS
    Cao, HT
    Niu, CI
    Zhang, ZC
    ACTA BIOCHIMICA ET BIOPHYSICA SINICA, 1996, 28 (02): : 164 - 169
  • [42] AFFINITY PURIFICATION OF OLIGOSACCHARIDES USING MONOCLONAL-ANTIBODIES
    ZOPF, D
    SCHROER, K
    HANSSON, G
    DAKOUR, J
    LUNDBLAD, A
    METHODS IN ENZYMOLOGY, 1987, 138 : 307 - 313
  • [43] Development of a method for purification of monoclonal antibodies utilizing precipitation
    Mutchler, Alison
    ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 2018, 255
  • [44] New affinity media for purification of monoclonal antibodies.
    Johansson, HJ
    Mattaqui-Tabar, A
    Karlsson, S
    ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 2004, 227 : U230 - U230
  • [45] Precipitation: A powerful tool for continuous purification of monoclonal antibodies
    Sommer, Ralf
    Tscheliessnig, Anne
    Schulz, Henk
    Helk, Bernhard
    Jungbauer, Alois
    NEW BIOTECHNOLOGY, 2014, 31 : S127 - S127
  • [46] Strategic Assay Selection for analytics in high-throughput process development: Case studies for downstream processing of monoclonal antibodies
    Konstantinidis, Spyridon
    Kong, Simyee
    Chhatre, Sunil
    Velayudhan, Ajoy
    Heldin, Eva
    Titchener-Hooker, Nigel
    BIOTECHNOLOGY JOURNAL, 2012, 7 (10) : 1256 - 1268
  • [47] Outsourcing of process development and manufacturing of monoclonal antibodies
    Martin, JMC
    CHIMICA OGGI-CHEMISTRY TODAY, 2001, 19 (06) : 22 - 25
  • [48] Accelerated purification process development of monoclonal antibodies for shortening time to clinic design and case study of chromatography processes
    Ishihara, Takashi
    Kadoya, Toshihiko
    JOURNAL OF CHROMATOGRAPHY A, 2007, 1176 (1-2) : 149 - 156
  • [49] Production and purification of monoclonal and polyclonal antibodies against cholera toxin
    Chou, SF
    HYBRIDOMA AND HYBRIDOMICS, 2004, 23 (04): : 258 - 261
  • [50] BIOT 79-Purification of monoclonal antibodies with affinity membranes
    Boi, Cristiana
    Sarti, Giulio C.
    ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 2006, 232
12345