IgA类单克隆抗体血型定型试剂研制和应用  

Establishment and clinical application of IgA monoclonal antibodies blood grouping reagents

作　　者：薛绍礼[1] 王怡[1] 夏觅真[1] 薛青[2] 宗琴珍 王晓琴 

机构地区：[1]安徽医科大学医学生物工程教研室,合肥230032 [2]首都医科大学2003级临床7年制1班 [3]合肥东南医学科技发展有限公司

出　　处：《现代临床医学生物工程学杂志》2006年第6期488-490,共3页Journal of Modern Clinical Medical Bioengineering

基　　金：国家火炬计划(97D231B3600291)

摘　　要：目的研制IgA类单克隆抗体血型定型试剂。方法根据新生物制品注册和《中国生物制品规程》等有关要求,筛选合适细胞株,建立生产工艺,对中试产品进行检定和临床试验。结果研究、选择了2株细胞株,建立了经济、实用的生产工艺,中试和正式生产的产品所有指标均达到或超过国家标准,通过国家法定检定,临床应用1亿人份以上,没出现血型错判或误判。结论研制成功国际唯一的IgA类单克隆抗体血型定型试剂。Objective To establish and apply IgA monoclonal antibodies blood grouping reagents. Methods The monoclonal antibodies were manufactured on a large scale, according to the State Requirements for Biologics and the Guides for Clinical Trials of New Drugs. The indexes concerned of the products were studied. Results Each of the results reached or surpassed the state standards. Conclusion IgA monoclonal antibodies blood grouping reagents are successfully established and applied.

关 键 词：IgA单克隆抗体 血型定型 试剂 研制 应用 

分 类 号：R392[医药卫生—免疫学]