国产mAbRh(D)血型定型试剂生产工艺和质量标准的建立及质量检定

The stabilizing of the production technology and the quality standard of national monoclonal reagents for rhesus-D typing and their quality control

目的建立国产mAbRh(D)血型定型试剂生产工艺和质量标准。方法运用细胞杂交技术生产抗Rh(D)单克隆抗体血型定型试剂。结果Rh(D)血型定型试剂的质量检定结果以及初步的临床验证资料表明 ,其主要性能指标完全符合质量标准。结论建立了国产mAbRh(D)血型定型试剂生产工艺和质量标准 ,国产mAbRh(D)

Purpose To stabilize the production technology and the quality standard of national monoclonal reagents for rhesus D typing.MethodsThey were established by using the production of monoclonal reagents for rhesus D typing based on hybridoma techniques. ResultsThe major characteristic index conforms to the established quality standard in accordance with the results of the quality control and of the preliminary clinical application.ConclusionThe production technology and the quality standard of national monoclonal reagents for rhesus D typing were stabilized. These national monoclonal reagents for rhesus D typing could substitute for the imported products used in our country.