Rapid Methods

Renate Rosengarten; Carl-Ulrich Zimmerman; Martina Sauert

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Rapid Methods

机译：快速方法

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Recent advances in mycoplasma testing using automated rapid NAT-based methods provide opportunities that can potentially revolutionise quality control and lot release and substantially impact biopharmaceutical manufacturing: Testing for the absence of mycoplasmas is an essential part of quality control (QC) measures in biopharmaceutical production processes. However, the detection of mycoplasmas by traditional culture methods, as required by official regulatory protocols, sometimes poses a major challenge. Hurdles include their small cell size, the wide diversity of species, the cell invasiveness of some species, their special nutrient requirements, the limited generation of turbidity in liquid culture and the non-cu!tivability of some species and strains in standard mycoplasma growth media. Therefore, low-grade mycoplasma contaminations might go unrecognised for a long time, as a number of spectacular mycoplasma contamination cases have previously shown. The often catastrophic consequences are lost production time and considerable revenue losses.

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来源
《European BioPharmaceutical Review》 |2017年第10期|共5页
作者
Renate Rosengarten; Carl-Ulrich Zimmerman; Martina Sauert;
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作者单位

Bacteriology and Hygiene at the University of Veterinary Medicine Vienna Austria;

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原文格式 PDF
正文语种 eng
中图分类药学;
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Rapid Methods

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