20160119 ECA新闻：生物技术生产的治疗蛋白免疫力评估指南草案

20160119 ECA新闻：生物技术生产的治疗蛋白免疫力评估指南草案公开征求意见直至1月底  

GMP News
19/01/2016

Draft guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins open for comments until end of January

生物技术生产的治疗蛋白免疫力评估指南草案公开征求意见直至1月底

In autumn 2015, the EMA published the "Draft guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins" This document is supposed to replace the "Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins from 2006.

在2015年秋天，EMA公布了“生物技术生产的治疗蛋白免疫力评估指南草案“。该文件意在取代2006年的“生物技术生产的治疗蛋白免疫力评估指南“。

The increasing number of biological/biotechnology-derived proteins used as therapeutic agents and the experiences from marketing authorisation applications on unwanted immune responses as well as other new information necessitated an update of the requirements for assays for immunogenicity and integrated analysis of the clinical significance of immunogenicity.

日益增长的生物制品/生物技术制备的蛋白用作治疗剂，上市许可申请中获得的关于非预期免疫反应的经验，以及其它新的信息需要对免疫力和临床免疫力显著性整合分析要求进行更新。

The new draft includes information about:

新指南草案包括以下信息：

• The legal basis and other relevant guidelines
• 法律依据和其它相关指南
• Factors that may influence the development of an immune response against a therapeutic protein
• 可能会影响对一个治疗蛋白的免疫反应的发展的影响
• Potential clinical consequences of immunogenicity
• 免疫力潜在临床后果
• Non-clinical assessment of immunogenicity and its consequences
• 免疫力和其后果的非临床评估
• Development of assays for detecting and measuring immune responses in humans
• 含量检测和人类免疫反应测量研发
• Immunogenicity and Clinical Development
• 免疫力和临床研发
• Pharmacovigilance
• 警戒
• Summary of the immunogenicity program
• 免疫力项目摘要
  

The EMA defines the scope of that draft as follows:

EMA定义该草案的范围如下：

"The general principles adopted and explained in this document mainly apply to the development of an unwanted immune response against a therapeutic protein in patients and to a systematic evaluation of it. The guideline applies to proteins and polypeptides, their derivatives, and products of which they are components, e.g. conjugates. These proteins and polypeptides are mainly produced by recombinant or non-recombinant expression systems. Throughout this guideline, the term “therapeutic protein” is used."

“在本文件中所采用和诠释的一般原则主要适用于患者对治疗性蛋白的非预期免疫反应的研究，以及对其进行系统性评估。指南适用于蛋白和多肽类，其衍生物，以及其作为组份的药品，如轭合物。这些蛋白质和多肽主要采用重组或非重组表达系统生产。在本指南中，使用了术语“治疗性蛋白质”。

More details can be found in the "Guideline on Immunogenicity assessment of  biotechnology-derived therapeutic proteins" which is open for comments until 31 January 2016.

更多细节，参见上网址指南，其公开征求意见截止2016年1月31日。

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