1.Prospects for plasma protein products in China
Changyong JIAN ; Fangyu DONG ; Chen CHEN ; An ZHOU ; Jiuyue ZHOU ; Xue DONG ; Cuiping ZHANG ; Dianwei SONG ; Bo ZHOU ; Shan MA
Chinese Journal of Blood Transfusion 2022;35(2):227-232
Plasma protein products, essential drugs for various clinical diseases, are therapeutic biological products extracted from healthy human plasma. The research and development of new plasma protein products, led by United States and European, has been widely deepened and enhanced. Therefore, accelerating the development of new plasma protein products in China is of great significance. This review summarizes the research and development of plasma protein products that have been marketed abroad but have not produced in China, as well as analyzes the difficulties and prospects of the development of plasma protein products in China.
2.Method for the detection of human immunoglobulin Fc function based on surface plasmon resonance: preliminary establishment and validation
Fangyu DONG ; Jiuyue ZHOU ; Chen CHEN ; An ZHOU ; Dianwei SONG ; Jianfeng GAO ; Xi CHEN ; Xiao LI ; Jiawei WU ; Jiacheng DU ; Bo ZHOU ; Changyong JIAN
Chinese Journal of Blood Transfusion 2022;35(4):396-399
【Objective】 To establish a method for detecting human immunoglobulin Fc function based on surface plasmon resonance technology. 【Methods】 Based on the characteristic that FcγRI can be binded to the Fc segment of IgG, the affinity constant of the sample was detected by surface plasmon resonance, and its Fc function was the KD ratio of the sample to the standard. The method was validated for specificity/specificity, precision and robustness. The method and the pharmacopoeia method were used to detect the Fc function of 30 human immunoglobulins, and the correlation and consistency of the detection results were analyzed. 【Results】 The method validation results showed that this method has strong specificity/specificity (t values were 0.15, 0.22, both P>0.05), good precision (CV value 5.37%~10.69%) and good robustness (CV value 10.06%). The detection results of this method and the pharmacopoeia method have high correlation (r=0.96, P<0.05) and high consistency (Bias-2.060, 95% Limits of Agreement-5.628~1.508). 【Conclusion】 A method for detecting human immunoglobulin Fc function based on surface plasmon resonance has been successfully established.