Establishment of European pharmacopoeia Mycoplasma reference strains.

Pharmeuropa bio Pub Date : 2006-11-01
C Milne, A Daas
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Abstract

European Pharmacopoeia (Ph. Eur.) general chapter 2.6.7. Mycoplasma requires for the culture test reference strains of mycoplasma field isolates with fewer than 15 passages for validation and run control and in the test for inhibitory substances. Low passage field isolates of 5 mycoplasma strains (Mycoplasma hyorhinis, Mycoplasma synoviae, Mycoplasma fermentans, Mycoplasma orale and Acholeplasma laidlawii) have been prepared for this purpose and a small scale collaborative study involving European laboratories was carried out to confirm the suitability of the material for the intended purpose. Strains were prepared as 1 ml samples in frozen format and are stored below -60 degrees C. Each laboratory determined a titre for the material on their in-house media. A secondary part of the study also compared the growth of prediluted samples on the different culture media. Results of the study confirm that the material is suitable for use as a biological reference preparation (BRP) and an estimated titre has been provided for each strain based on the results of the study. It was noted that differences in the culture media used in the different laboratories did not have a detrimental effect on titre estimation. The estimated titre is intended as a guide for users to validate the use of the reference material in house. The candidate BRPs were adopted by the European Pharmacopoeia Commission on June 28, 2006 and are available for use from EDQM. A revision to chapter 2.6.7, including reference to the use of nucleic acid amplification techniques (NAT) was also adopted in June 2006 and will appear in the European Pharmacopoeia version 5.8 in January 2007 and come into force the 1st of July 2007. While it was not part of the study a number of participants also performed in-house NAT assays on the study material. Preliminary findings from these studies are presented.

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欧洲药典支原体标准菌株的建立。
欧洲药典通论第2.6.7章。支原体培养试验要求支原体野外分离株少于15传代进行验证、运行对照和抑制物质试验的对照菌株。为此目的制备了5种支原体菌株(嗜鼻支原体、滑膜支原体、发酵支原体、口腔支原体和laidlai支原体)的低传代野外分离株,并开展了一项涉及欧洲实验室的小规模合作研究,以确认该材料是否适合预期目的。将菌株制备为1ml样品,冷冻保存在-60℃以下,每个实验室在其内部培养基上确定材料的滴度。研究的第二部分还比较了预稀释样品在不同培养基上的生长情况。研究结果证实该材料适合用作生物参比制剂(BRP),并根据研究结果为每个菌株提供了估计滴度。有人指出,不同实验室使用的培养基的差异对滴度估计没有不利影响。估计滴度的目的是作为用户在内部验证参考物质使用的指南。候选brp已于2006年6月28日被欧洲药典委员会通过,并可从EDQM中使用。对第2.6.7章的修订,包括对核酸扩增技术(NAT)使用的参考,也于2006年6月通过,并将于2007年1月出现在欧洲药典5.8版中,并于2007年7月1日生效。虽然这不是研究的一部分,但许多参与者也对研究材料进行了内部NAT分析。本文介绍了这些研究的初步结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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