Clarification of vaccines: An overview of filter based technology trends and best practices

被引：59

作者：

Besnard, Lise ^{[1
]}

Fabre, Virginie ^{[1
,7
]}

Fettig, Michael ^{[2
]}

Gousseinov, Elina ^{[3
]}

Kawakami, Yasuhiro ^{[4
]}

Laroudie, Nicolas ^{[5
]}

Scanlan, Claire ^{[2
]}

Pattnaik, Priyabrata ^{[6
]}

机构：

[1] Sanofi Pasteur, F-69280 Marcy Letoile, France

[2] EMD Millipore Corp, Billerica, MA USA

[3] EMD Millipore, Unit 5, Toronto, ON M9W 6Y1, Canada

[4] Merck Ltd, DiverCity Tokyo Off, Koto Ku, Tokyo 1350064, Japan

[5] Millipore SAS, F-78280 Guyancourt, France

[6] Merck Pte Ltd, Singapore 117528, Singapore

[7] Genzyme Polyclonals SAS, F-69007 Lyon, France

来源：

BIOTECHNOLOGY ADVANCES | 2016年 / 34卷 / 01期

关键词：

Vaccine; Clarification; Filtration; Purification; Normal flow filtration; Tangential flow filtration; Harvest; Viral vaccine; Conjugated polysaccharide vaccine; Bacterial vaccine; VIRUS-LIKE PARTICLES; TANGENTIAL FLOW FILTRATION; PLASMID DNA VACCINES; CAPSULAR POLYSACCHARIDE; PURIFICATION PROCESSES; ALLANTOIC FLUID; VIRAL VECTORS; GENE-THERAPY; RECOVERY; FLOCCULATION;

D O I：

10.1016/j.biotechadv.2015.11.005

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：

Vaccines are derived from a variety of sources including tissue extracts, bacterial cells, virus particles, recombinant mammalian, yeast and insect cell produced proteins and nucleic acids. The most common method of vaccine production is based on an initial fermentation process followed by purification. Production of vaccines is a complex process involving many different steps and processes. Selection of the appropriate purification method is critical to achieving desired purity of the final product. Clarification of vaccines is a critical step that strongly impacts product recovery and subsequent downstream purification. There are several technologies that can be applied for vaccine clarification. Selection of a harvesting method and equipment depends on the type of cells, product being harvested, and properties of the process fluids. These techniques include membrane filtration (microfiltration, tangential-flow filtration), centrifugation, and depth filtration (normal flow filtration). Historically vaccine harvest clarification was usually achieved by centrifugation followed by depth filtration. Recently membrane based technologies have gained prominence in vaccine clarification. The increasing use of single use technologies in upstream processes necessitated a shift in harvest strategies. This review offers a comprehensive view on different membrane based technologies and their application in vaccine clarification, outlines the challenges involved and presents the current state of best practices in the clarification of vaccines. (C) 2015 Elsevier Inc. All rights reserved.

引用

页码：1 / 13

页数：13

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