Willkommen Hannelore, Blümel Johannes, Brorson Kurt, Chen Dayue, Chen Qi, Gröner Albrecht, Kreil Thomas R, Ruffing Michel, Ruiz Sol, Scott Dorothy, Silvester Glenda
Regulatory Affairs & Biological Safety Consulting, Erzhausen, Germany.
Paul-Ehrlich Institut, Langen, Germany.
PDA J Pharm Sci Technol. 2016 Mar-Apr;70(2):177-88. doi: 10.5731/pdajpst.2016.006569. Epub 2016 Mar 28.
The report provides a summary of the presentations at the Virus & TSE Safety Forum 2015 organized by the Parenteral Drug Association (PDA) and held in Cascais, Portugal, from 9 to 11 June, 2015. As with previous conferences of this series, the PDA Virus & TSE Safety Forum 2015 provided an excellent forum for the exchange of information and opinions between the industry, research organizations, and regulatory bodies. Regulatory updates on virus and TSE safety aspects illustrating current topics of discussion at regulatory agencies in Europe and the United States were provided; the conference covered emerging viruses and new virus detection systems that may be used for the investigation of human pathogenic viruses as well as the virus safety of cell substrates and of raw material of ovine/caprine or human origin. Progress of development and use of next-generation sequencing methods was shown by several examples. Virus clearance data illustrating the effectiveness of inactivation or removal methods were presented and data provided giving insight into the mechanism of action of these technologies. In the transmissible spongiform encephalopathy (TSE) part of the conference, the epidemiology of variant Creutzfeldt-Jakob disease was reviewed and an overview about diagnostic tests provided; current thinking about the spread and propagation of prions was presented and the inactivation of prions by disinfection (equipment) and in production of bovine-derived reagents (heparin) shown. The current report provides an overview about the outcomes of the 2015 PDA Virus & TSE Safety Forum, a unique event in this field.
本报告总结了由注射剂协会（PDA）组织、于2015年6月9日至11日在葡萄牙卡斯凯什举行的2015年病毒与传染性海绵状脑病（TSE）安全论坛上的发言内容。与本系列以往会议一样，2015年PDA病毒与TSE安全论坛为行业、研究机构和监管机构之间交流信息和意见提供了一个绝佳的平台。报告提供了欧洲和美国监管机构关于病毒和TSE安全方面的监管更新情况，阐述了当前的讨论话题；会议涵盖了可能用于调查人类致病病毒的新兴病毒和新病毒检测系统，以及细胞基质和羊/山羊或人类来源原材料的病毒安全性。通过几个实例展示了下一代测序方法的开发和使用进展。展示了说明灭活或去除方法有效性的病毒清除数据，并提供了深入了解这些技术作用机制的数据。在会议的传染性海绵状脑病（TSE）部分，回顾了变异型克雅氏病的流行病学情况并提供了诊断测试概述；介绍了目前关于朊病毒传播和增殖的观点，并展示了通过消毒（设备）和在牛源试剂（肝素）生产中使朊病毒失活的情况。本报告概述了2015年PDA病毒与TSE安全论坛的成果，这是该领域的一次独特活动。
