Cation exchange chromatography performed in overloaded mode is effective in removing viruses during the manufacturing of monoclonal antibodies

Masuda Yumiko; Tsuda Masashi; Hashikawa‐Muto Chie; Takahashi Yusuke; Nonaka Koichi; Wakamatsu Kaori

摘要

Abstract >Viral safety is a critical concern with regard to monoclonal antibody (mAb) products produced in mammalian cells such as Chinese hamster ovary cells. Manufacturers are required to ensure the safety of such products by validating the clearance of viruses in downstream purification steps. Cation exchange (CEX) chromatography is widely used in bind/elute mode as a polishing step in mAb purification. However, bind/elute modes require a large volume of expensive resin. To reduce the production cost, the use of CEX chromatography in overloaded mode has recently been investigated. The viral clearance ability in overloaded mode was evaluated using murine leukemia virus (MLV). Even under high‐load conditions such as 2,000?g mAb/L resin, MLV was removed from mAb solutions. This viral clearance ability was not significantly affected by resin type or mAb type. The overloaded mode can also remove other types of viruses such as pseudorabies virus and reovirus Type 3 from mAb solutions. Based on these results, this cost‐effective overloaded mode is comparable to the bind‐elute mode in terms of viral removal. </abstract> </span> <span class="z_kbtn z_kbtnclass hoverxs" style="display: none;">展开▼</span> </div> <div class="translation abstracttxt"> <span class="zhankaihshouqi fivelineshidden" id="abstract"> <span>机译：</span><Abstract Type =“Main”XML：Lang =“en”> <标题类型=“main”>抽象</ title> >病毒安全是关于在哺乳动物细胞如中国仓鼠卵巢细胞中产生的单克隆抗体（MAB）产品的关键问题。制造商需要通过在下游纯化步骤中验证病毒的间隙来确保这些产品的安全性。阳离子交换（CEX）色谱被广泛用于粘合/洗脱模式，作为MAB净化的抛光步骤。然而，粘合/洗脱模式需要大量的昂贵树脂。为降低生产成本，最近研究了在过载模式下使用CEX色谱法。使用小鼠白血病病毒（MLV）评估过载模式的病毒间隙能力。即使在高负荷条件下，如2,000？G mAb / L树脂，也从MAB溶液中除去MLV。这种病毒间隙能力不受树脂类型或MAB型的显着影响。过载模式还可以从MAB溶液中去除其他类型的病毒，例如伪毒性病毒和reoVirus类型3。基于这些结果，这种经济高效的过载模式与病毒去除方面的结合洗脱模式相当。</ p> </摘要> </span> <span class="z_kbtn z_kbtnclass hoverxs" style="display: none;">展开▼</span> </div> </div> <div class="record"> <h2 class="all_title" id="enpatent33" >著录项</h2> <ul> <li> <span class="lefttit">来源</span> <div style="width: 86%;vertical-align: text-top;display: inline-block;"> <a href='/journal-foreign-15005/'>《Biotechnology Progress》</a> <b style="margin: 0 2px;">|</b><span>2019年第5期</span><b style="margin: 0 2px;">|</b><span>共8页</span> </div> </li> <li> <div class="author"> <span class="lefttit">作者</span> <p id="fAuthorthree" class="threelineshidden zhankaihshouqi"> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Masuda Yumiko&option=202" target="_blank" rel="nofollow">Masuda Yumiko;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Tsuda Masashi&option=202" target="_blank" rel="nofollow">Tsuda Masashi;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Hashikawa‐Muto Chie&option=202" target="_blank" rel="nofollow">Hashikawa‐Muto Chie;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Takahashi Yusuke&option=202" target="_blank" rel="nofollow">Takahashi Yusuke;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Nonaka Koichi&option=202" target="_blank" rel="nofollow">Nonaka Koichi;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Wakamatsu Kaori&option=202" target="_blank" rel="nofollow">Wakamatsu Kaori;</a> </p> <span class="z_kbtnclass z_kbtnclassall hoverxs" id="zkzz" style="display: none;">展开▼</span> </div> </li> <li> <div style="display: flex;"> <span class="lefttit">作者单位</span> <div style="position: relative;margin-left: 3px;max-width: 639px;"> <div class="threelineshidden zhankaihshouqi" id="fOrgthree"> <p>Biologics Technology Research LaboratoriesDaiichi Sankyo Co. Ltd.Ohra‐gun Gunma Japan;</p> <p>Biologics Technology Research LaboratoriesDaiichi Sankyo Co. Ltd.Ohra‐gun Gunma Japan;</p> <p>Biologics Technology Research LaboratoriesDaiichi Sankyo Co. Ltd.Ohra‐gun Gunma Japan;</p> <p>Biologics Technology Research LaboratoriesDaiichi Sankyo Co. Ltd.Ohra‐gun Gunma Japan;</p> <p>Biologics Technology Research LaboratoriesDaiichi Sankyo Co. Ltd.Ohra‐gun Gunma Japan;</p> <p>Graduate School of Science and TechnologyGunma UniversityKiryu‐shi Gunma Japan;</p> </div> <span class="z_kbtnclass z_kbtnclassall hoverxs" id="zhdw" style="display: none;">展开▼</span> </div> </div> </li> <li > <span class="lefttit">收录信息</span> <span style="width: 86%;vertical-align: text-top;display: inline-block;"></span> </li> <li> <span class="lefttit">原文格式</span> <span>PDF</span> </li> <li> <span class="lefttit">正文语种</span> <span>eng</span> </li> <li> <span class="lefttit">中图分类</span> <span><a href="https://www.zhangqiaokeyan.com/clc/15.html" title="生物科学">生物科学;</a></span> </li> <li class="antistop"> <span class="lefttit">关键词</span> <p style="width: 86%;vertical-align: text-top;"> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=cation exchange chromatography&option=203" rel="nofollow">cation exchange chromatography;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=monoclonal antibody&option=203" rel="nofollow">monoclonal antibody;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=overloaded mode&option=203" rel="nofollow">overloaded mode;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=purification&option=203" rel="nofollow">purification;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=viral clearance&option=203" rel="nofollow">viral clearance;</a> </p> <div class="translation"> 机译：阳离子交换色谱;单克隆抗体;过载模式;纯化;病毒间隙; </div> </li> </ul> </div> </div> <div class="literature cardcommon"> <div class="similarity "> <h3 class="all_title" id="enpatent66">相似文献</h3> <div class="similaritytab clearfix"> <ul> <li class="active" >外文文献</li> <li >中文文献</li> <li >专利</li> </ul> </div> <div class="similarity_details"> <ul > <li> <div> <b>1. </b><a class="enjiyixqcontent" 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Yujia Jin</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Cheng Lei&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,Cheng Lei</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Dan Hu&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,Dan Hu</a> <span> <a href="/journal-cn-6694/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 中国高等学校学术文摘·医学 </a> </span> <span> . 2017</span><span>,第004期</span> </span> </div> </li> <li> <div> <b>3. </b><a class="enjiyixqcontent" href="/academic-journal-cn_virologica-sinica_thesis/0201223208848.html">Human Monoclonal Antibodies as Candidate Therapeutics Against Emerging Viruses and HIV-1</a> <b>[J]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Zhongyu Zhu&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . Zhongyu Zhu</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Ponraj Prabakaran&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,Ponraj Prabakaran</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Weizao Chen&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,Weizao Chen</a> <span> <a href="/journal-cn-5783/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 中国病毒学 </a> </span> <span> . 2013</span><span>,第002期</span> </span> </div> </li> </ul> <ul style="display: none;"> <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/patent-detail/06130407522466.html">Cation exchange chromatography carrier for antibody purification and method for separating antibody monomers and their polymers produced in the process of manufacturing antibody pharmaceuticals</a> <b>[P]</b> . <span> 外国专利：  JP6340317B2 </span> <span> . 2018-06-06</span> </div> <p class="zwjiyix translation" style="max-width: initial;height: auto;word-break: break-all;white-space: initial;text-overflow: initial;overflow: initial;"> <span>机译：用于抗体纯化的阳离子交换色谱载体以及分离在抗体药物生产过程中生产的抗体单体及其聚合物的方法 </span> </p> </li> <li> <div> <b>2. </b><a class="enjiyixqcontent" href="/patent-detail/06130413742459.html">CATION EXCHANGE CHROMATOGRAPHY CARRIER FOR REFINING OF ANTIBODIES, AND METHOD FOR SEPARATION OF ANTIBODY MONOMERS FROM POLYMERS THEREOF PRODUCED IN ANTIBODY DRUG MANUFACTURING PROCESS</a> <b>[P]</b> . <span> 外国专利：  EP2910943A4 </span> <span> . 2016-07-13</span> </div> <p class="zwjiyix translation" style="max-width: initial;height: auto;word-break: break-all;white-space: initial;text-overflow: initial;overflow: initial;"> <span>机译：阳离子交换层析载体，用于纯化抗体，以及从抗体制备过程中制备的聚合物中分离抗体单体的方法 </span> </p> </li> <li> <div> <b>3. </b><a class="enjiyixqcontent" href="/patent-detail/06130414340911.html">CATION EXCHANGE CHROMATOGRAPHY CARRIER FOR REFINING OF ANTIBODIES, AND METHOD FOR SEPARATION OF ANTIBODY MONOMERS FROM POLYMERS THEREOF PRODUCED IN ANTIBODY DRUG MANUFACTURING PROCESS</a> <b>[P]</b> . <span> 外国专利：  EP2910943A1 </span> <span> . 2015-08-26</span> </div> <p class="zwjiyix translation" style="max-width: initial;height: auto;word-break: break-all;white-space: initial;text-overflow: initial;overflow: initial;"> <span>机译：阳离子交换层析载体，用于纯化抗体，以及从抗体制备过程中制备的聚合物中分离抗体单体的方法 </span> </p> </li> </ul> </div> </div> </div> <div class="theme cardcommon" style="overflow: auto;display:none"> <h3 class="all_title" id="enpatent55">相关主题</h3> <ul id="subject"> </ul> </div> </div> </div> </div> <div class="right rightcon"> <div class="details_img cardcommon clearfix" style="margin-bottom: 10px;display:none;" > </div> </div> </div> <div id="thesis_get_original1" class="downloadBth" style="bottom: 19px;z-index: 999;" onclick="ywcd('0704028287844','4',7,2,1,'',this,24)" class="delivery" prompt="010401" title="通过人工服务将文献原文发送至邮箱" >获取原文</div> <div class="journalsub-pop-up" style="display: none"> <div class="journal-sub"> 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