Mackay David, Kriz Nikolaus
EMEA, 7 Westferry Circus, Canary Wharf, London E144HB, United Kingdom.
Biologicals. 2010 May;38(3):335-7. doi: 10.1016/j.biologicals.2010.01.014. Epub 2010 Mar 24.
There are three principal elements related to viral safety in the context of immunological veterinary medicinal products: the presence of extraneous agents in either raw material used for production or in the finished product, residual pathogenicity of live viruses used as active ingredients, and incomplete inactivation of inactivated viruses used as active ingredients. Although the approach to controlling these areas of risk has not substantially changed in the recent past, a number of events, combined with advances in science and changes in the regulatory approach, make it timely to review the requirements in this area. This article reviews the major areas of change and progress with respect to the viral safety of immunological veterinary medicinal products and identifies current challenges from the perspectives of both industry and regulators.
在免疫兽用药品领域，与病毒安全性相关的主要有三个要素：生产所用原材料或成品中存在外来因子、用作活性成分的活病毒的残余致病性，以及用作活性成分的灭活病毒的不完全灭活。尽管在最近一段时间内控制这些风险领域的方法没有实质性变化，但一些事件，再加上科学的进步和监管方法的改变，使得及时审查该领域的要求变得很有必要。本文回顾了免疫兽用药品病毒安全性方面的主要变化和进展领域，并从行业和监管机构的角度确定了当前面临的挑战。
