本文選題：單克隆抗體　切入點(diǎn)：電荷異質(zhì)性　出處：《藥物分析雜志》2017年08期

【摘要】：目的:對(duì)4種常用的單抗電荷異質(zhì)性分析方法進(jìn)行比對(duì)研究。方法:以重組抗TNFα全人源單克隆抗體為例,分別利用離子交換色譜(IEC)、毛細(xì)管區(qū)帶電泳(CZE)、毛細(xì)管等電聚焦電泳(CIEF)和成像毛細(xì)管等電聚焦電泳(iCIEF)4種方法對(duì)該抗體的電荷異質(zhì)性進(jìn)行分析;利用CIEF和iCIEF 2種方法對(duì)抗體主峰等電點(diǎn)(pI)進(jìn)行分析。結(jié)果:4種方法能夠?qū)χ亟M抗TNFα全人源單克隆抗體的電荷異構(gòu)體進(jìn)行有效的分離和定量,其中IEC和CZE 2種方法檢測(cè)的電荷異構(gòu)體峰面積百分比(酸性峰、主峰和堿性峰)較為一致,4種方法檢測(cè)的堿性峰比例較一致,CIEF和iCIEF檢測(cè)的主峰與酸性峰比例較其他方法偏高。CIEF和iCIEF檢測(cè)抗體主峰等電點(diǎn)具有一定差異,其中,聚焦時(shí)間長(zhǎng)短和pI Marker的選擇是影響單抗pI值檢測(cè)的主要因素。結(jié)論:通過(guò)抗體電荷異質(zhì)性分析方法的比較研究可見(jiàn),在單抗電荷異構(gòu)體比例和主峰pI測(cè)定上4種方法具有一定的差異。對(duì)單抗的質(zhì)控應(yīng)結(jié)合產(chǎn)品特性和表征研究,合理選擇電荷異質(zhì)性分析方法。
[Abstract]:Objective: to compare and study four common methods for the analysis of the charge heterogeneity of monoclonal antibodies (McAbs). Methods: the recombinant monoclonal antibody against TNF 偽 was used as an example. The charge heterogeneity of the antibody was analyzed by ion-exchange chromatography (IEC), capillary zone electrophoresis (CZE), capillary isoelectric focusing electrophoresis (CIEF) and imaging capillary isoelectric focusing electrophoresis (iCIEF). The main peak isoelectric point (Pi) of the antibody was analyzed by CIEF and iCIEF. Results the charge-isomers of the recombinant anti-human monoclonal antibody against TNF 偽 could be effectively separated and quantified by the two methods. The charge isomer peak area percentage detected by IEC and CZE methods (acid peak, acid peak, acid peak, acid peak, acid peak, acid peak, acid peak, acid peak). The ratio of main peak and acid peak detected by iCIEF and iCIEF were higher than those of other methods, and the isoelectric point of main peak of antibody detected by iCIEF was higher than that of other methods, among them, the ratio of main peak to acid peak was higher than that of other methods, and the ratio of main peak to acid peak was higher than that of other methods. The length of focus time and the selection of Pi Marker are the main factors influencing the detection of Pi value of monoclonal antibody. Conclusion: through the comparison of antibody charge heterogeneity analysis, we can see that, There are some differences in the ratio of charge isomers of McAb and the determination of main peak Pi. The quality control of McAbs should be combined with the study of product characteristics and characterization, and the analysis method of charge heterogeneity should be reasonably selected.
【作者單位】： 中國(guó)食品藥品檢定研究院?jiǎn)慰寺】贵w產(chǎn)品室衛(wèi)生部生物技術(shù)產(chǎn)品檢定及標(biāo)準(zhǔn)化重點(diǎn)實(shí)驗(yàn)室;
【基金】：國(guó)家“重大新藥創(chuàng)制”科技重大專項(xiàng)資助項(xiàng)目(2014ZX09304311-001,2012ZX09304010)
【分類號(hào)】：R392-33

【相似文獻(xiàn)】

相關(guān)期刊論文 前6條

1 左瑾,方福德,丁濂,謝大英;谷胱甘肽S-轉(zhuǎn)移酶異質(zhì)性研究[J];基礎(chǔ)醫(yī)學(xué)與臨床;1991年02期

2 牟奕,嚴(yán)明,單祥年;線粒體的多態(tài)性、異質(zhì)性與線粒體疾病研究[J];國(guó)外醫(yī)學(xué).遺傳學(xué)分冊(cè);2000年02期

3 康德英,王家良,洪旗,劉關(guān)鍵;臨床試驗(yàn)Meta分析中的異質(zhì)性評(píng)價(jià)研究[J];華西醫(yī)學(xué);2000年02期

4 謝憶虹,彭梅,龔金蓮,萬(wàn)唐;異質(zhì)性耐萬(wàn)古霉素葡萄球菌的篩查與分析[J];中華微生物學(xué)和免疫學(xué)雜志;2004年08期

5 李麗;李霞;陳義漢;郭政;姜偉;張瑞杰;饒紹奇;;基于耦合雙向聚類技術(shù)的DLBCL異質(zhì)性分析[J];遺傳;2006年09期

6 王軍奎,崔長(zhǎng)琮,陳新義,姚曉偉,姚青海,廉姜芳;Na~+/Ca~(2+)交換體電流在兔左心室壁分布的異質(zhì)性[J];四川大學(xué)學(xué)報(bào)(醫(yī)學(xué)版);2004年04期

，

本文編號(hào)：1679105