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莱氏无胆甾原体在生物制药生产所用培养基产品中的生长及长期存活情况。

The growth and long term survival of Acholeplasma laidlawii in media products used in biopharmaceutical manufacturing.

作者信息

Windsor Helena M, Windsor G David, Noordergraaf J H

机构信息

Mycoplasma Experience Ltd, 1 Norbury Road, Reigate, Surrey, RH2 9BY, UK.

出版信息

Biologicals. 2010 Mar;38(2):204-10. doi: 10.1016/j.biologicals.2009.11.009. Epub 2010 Feb 12.

Abstract

Acholeplasma laidlawii is a potential contaminant of bovine serum and has also been found as a contaminant in serum free cell culture media products. Anecdotal evidence of A. laidlawii contamination of tryptone soya broth circulated for a number of years before it was acknowledged that the organism could contaminate microbiological broth powders. The occasional occurrence of A. laidlawii in broth powders and possibly in powdered components of cell culture media as part of the normal bioburden poses a serious threat to routine pharmaceutical and biopharmaceutical operations where filtration is the sterilisation method of choice. Absence of visual evidence of contamination cannot be relied upon as there is variation with both organism strain and media product in the ability to produce turbidity. Strains of A. laidlawii which have been isolated from broth powders are not significantly different in temperature or media preferences from other strains. A. laidlawii is capable of growing to high titre at refrigeration and ambient temperatures in unsupplemented bacteriological sterility media or serum free cell culture media and can survive for prolonged periods in these products.

摘要

莱氏无胆甾原体是牛血清的一种潜在污染物,在无血清细胞培养基产品中也被发现是污染物。在人们认识到该微生物可污染微生物肉汤粉之前,关于胰蛋白胨大豆肉汤被莱氏无胆甾原体污染的传闻证据已经流传了数年。作为正常生物负载的一部分,莱氏无胆甾原体偶尔出现在肉汤粉中,也可能出现在细胞培养基的粉末成分中,这对以过滤作为首选灭菌方法的常规制药和生物制药操作构成了严重威胁。不能依赖没有污染的视觉证据,因为产生浑浊的能力在菌株和培养基产品方面都存在差异。从肉汤粉中分离出的莱氏无胆甾原体菌株在温度或培养基偏好方面与其他菌株没有显著差异。莱氏无胆甾原体能够在未添加营养成分的细菌无菌培养基或无血清细胞培养基中在冷藏和环境温度下生长到高滴度,并且可以在这些产品中长时间存活。

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