Size analysis of residual host cell DNA in cell culture-produced vaccines by capillary gel electrophoresis

被引：22

作者：

Shen, Xuan ^{[1
]}

Chen, Xiaomu ^{[1
]}

Tabor, David E. ^{[1
]}

Liu, Yi ^{[1
]}

Albarghouthi, Methal ^{[1
]}

Zhang, Yi-Fan ^{[1
]}

Galinski, Mark S. ^{[1
]}

机构：

[1] MedImmune, Mountain View, CA 94043 USA

来源：

BIOLOGICALS | 2013年 / 41卷 / 03期

关键词：

Cell culture-produced vaccines; Residual DNA; Capillary electrophoresis; ACTIVATED H-RAS; ELECTROKINETIC INJECTION; VIRAL-DNA; SEPARATION; SAFETY; MICE;

D O I：

10.1016/j.biologicals.2012.12.001

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Residual host cell DNA poses potential safety concerns for cell culture-derived vaccines or other biological products. In addition to the quantity of residual DNA, the size distribution is an important measure for determination of its associated risk factor. We have developed a new method for residual DNA size analysis, based on capillary gel electrophoresis (CGE) technology with sensitive laser induced fluorescence detection (LIF). The performance of this method was optimized through empirical selection of appropriate testing conditions and optimized conditions are presented. Examples are given to demonstrate the successful employment of this method for residual DNA size analysis of cell culture-produced vaccine samples. (C) 2012 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

引用

页码：201 / 208

页数：8

共 31 条

[1] Vero cell platform in vaccine production: moving towards cell culture-based viral vaccines
Barrett, P. Noel
Mundt, Wolfgang
Kistner, Otfried
Howard, M. Keith
[J]. EXPERT REVIEW OF VACCINES, 2009, 8 (05) : 607 - 618
[2] Capillary electrophoresis as a versatile tool for the bioanalysis of drugs - a review
Boone, CM
Waterval, JCM
Lingeman, H
Ensing, K
Underberg, WJM
[J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1999, 20 (06) : 831 - 863
[3] Influence of the electrokinetic injection conditions on the separation of DNA fragments in capillary electrophoresis
Catai, JR
Carrilho, E
[J]. JOURNAL OF THE BRAZILIAN CHEMICAL SOCIETY, 2004, 15 (03) : 413 - 420
[4] Simplex optimization of electrokinetic injection of DNA in capillary electrophoresis using dilute polymer solution
Catai, JR
Carrilho, E
[J]. ELECTROPHORESIS, 2003, 24 (04) : 648 - 654
[5] FluBlok, a next generation influenza vaccine manufactured in insect cells
Cox, Manon M. J.
Hollister, Jason R.
[J]. BIOLOGICALS, 2009, 37 (03) : 182 - 189
[6] Applications of capillary electrophoresis on microchip
Dolnik, V
Liu, SR
[J]. JOURNAL OF SEPARATION SCIENCE, 2005, 28 (15) : 1994 - 2009
[7] Doroshenko A, 2009, EXPERT REV VACCINES, V8, P679, DOI [10.1586/erv.09.31, 10.1586/ERV.09.31]
[8] Griffiths E, 2001, Dev Biol (Basel), V106, P25
[9] Griffiths E., 2001, DEV BIOL BASEL, V106, P35
[10] Gel and polymer-solution mediated separation of Biopolymers by capillary electrophoresis
Guttman, A
[J]. JOURNAL OF CHROMATOGRAPHIC SCIENCE, 2003, 41 (09) : 449 - 459

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