The scope of mycoplasma contamination within the biopharmaceutical industry
The scope of mycoplasma contamination within the biopharmaceutical industry
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DOI：
10.1016/j.biologicals.2010.03.002
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发表时间：
2010-03-01
期刊：
影响因子：
1.7
通讯作者：
Lundin, Daniel J.
中科院分区：
文献类型：
--
作者：
Armstrong, Shayn E.;Mariano, Jill A.;Lundin, Daniel J.
支原体是生物制药从研究阶段到临床开发和生产过程中遇到的最普遍和最严重的微生物污染物之一。Robinson等人首先发现了细胞培养系统中支原体污染的可能性。1956年[1]。目前，已建立的细胞培养中的污染率报告在15%到35%之间，在某些选定的人群中出现的比例相当高[2]。在过去的几年里，随着快速微生物方法的发展和验证，支原体检测的诊断方法得到了扩展。这项研究的目的是确定以客户为基础的人群中细胞培养物、细胞底物和生物制品的支原体感染的当前水平。对40,000个样本结果进行了回溯性比较，以确定四(4)个单独分析方法的总污染率。建立参考数据，如现有的污染率，在支原体快速微生物检测方法的关键评估中变得重要。(C)2010年国际生物制品协会。爱思唯尔有限公司出版。保留所有权利。
Mycoplasma is well recognized as one of the most prevalent and serious microbial contaminants encountered within the manufacturing of biopharmaceuticals from the research phase to clinical development and production. The potential for mycoplasma contamination within cell culture systems was first identified by Robinson et al. in 1956 [1]. Presently, contamination rates in established cell cultures have been reported between 15 and 35% with considerably higher occurrence cited in certain selected populations [2]. In the last few years, there has been an expansion of diagnostic approaches for mycoplasma detection with the development and validation of rapid microbiological methods. The objective of this study was to determine current levels of mycoplasma infection of cell cultures, cell substrates and biologicals within a client based population. Retrospective comparison of 40,000 sample results was done to determine total contaminations rates amongst four (4) individual analytical assays. The establishment of reference data, such as existing contamination rates, becomes important in the critical appraisal of rapid microbiological methods for the detection of mycoplasma. (C) 2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.