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Hybrid optimization of preparative chromatography for a ternary monoclonal antibody mixture

机译：三元单克隆抗体混合物制备色谱法的杂化优化

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Abstract >In the purification of monoclonal antibodies, ion‐exchange chromatography is typically used among the polishing steps to reduce the amount of product‐related impurities such as aggregates and fragments, whilst simultaneously reducing HCP, residual Protein A and potential toxins and viruses. When the product‐related impurities are difficult to separate from the products, the optimization of these chromatographic steps can be complex and laborious. In this paper, we optimize the polishing chromatography of a monoclonal antibody from a challenging ternary feed mixture by introducing a hybrid approach of the simplex method and a form of local optimization. To maximize the productivity of this preparative bind‐and‐elute cation‐exchange chromatography, wide ranges of the three critical operational parameters—column loading, the initial salt concentration, and gradient slope—had to be considered. The hybrid optimization approach is shown to be extremely effective in dealing with this complex separation that was subject to multiple constraints based on yield, purity, and product breakthrough. Furthermore, it enabled the generation of a large knowledge space that was subsequently used to study the sensitivity of the objective function. Increased design space understanding was gained through the application of Monte Carlo simulations. Hence, this work proposes a powerful hybrid optimization method, applied to an industrially relevant process development challenge. The properties of this approach and the results and insights gained, make it perfectly suited for the rapid development of biotechnological unit operations during early‐stage bioprocess development. </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> 在单克隆抗体的纯化中，在抛光步骤中通常使用离子交换色谱法，以减少物质相关的杂质，例如聚集体和片段，同时还原HCP，残留蛋白A和潜在的毒素和病毒。当产品相关的杂质难以与产品分离时，这些色谱步骤的优化可以复杂和艰苦。在本文中，通过引入单纯性方法的混合方法和局部优化形式，优化来自挑战三元饲料混合物的单克隆抗体的抛光色谱。为了最大化该制备结合和洗脱阳离子 - 交换色谱的生产率，必须考虑三个临界操作参数柱负载，初始盐浓度和梯度坡度的宽范围。混合优化方法在处理基于产量，纯度和产品突破的情况下，在处理这种复杂的分离时非常有效。此外，它使得能够产生随后用于研究目标函数的灵敏度的大知识空间。通过应用Monte Carlo模拟来获得增加的设计空间理解。因此，这项工作提出了一种强大的混合优化方法，适用于工业相关的过程开发挑战。这种方法的性质和所获得的结果和见解，使得在早期生物过程开发期间生物技术单位操作的快速发展完全适合发展。</ 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12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=Fischer Vivien&option=202" target="_blank" rel="nofollow">Fischer Vivien;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Kucia‐Tran Richard&option=202" target="_blank" rel="nofollow">Kucia‐Tran Richard;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Lewis William J.&option=202" target="_blank" rel="nofollow">Lewis William J.;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Velayudhan Ajoy&option=202" target="_blank" rel="nofollow">Velayudhan Ajoy;</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>Department of Biochemical Engineering The Advanced Centre for Biochemical EngineeringUniversity College LondonLondon UK;</p> <p>Biopharm Process ResearchBioPharm R&</p> <p>D GlaxoSmithKineStevenage UK;</p> <p>Biopharm Process ResearchBioPharm R&</p> <p>D GlaxoSmithKineStevenage UK;</p> <p>Department of Biochemical Engineering The Advanced Centre for Biochemical EngineeringUniversity College LondonLondon UK;</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=antibody purification&option=203" rel="nofollow">antibody purification;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=constrained experimental simplex optimization&option=203" rel="nofollow">constrained experimental simplex optimization;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=design space&option=203" rel="nofollow">design space;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=early‐stage bioprocess development&option=203" rel="nofollow">early‐stage bioprocess development;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=preparative scale polishing chromatography&option=203" rel="nofollow">preparative scale polishing chromatography;</a> </p> <div class="translation"> 机译：抗体净化;受限制的实验单纯x优化;设计空间;早期生物过程开发;制备规模抛光色谱; </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" href="/academic-journal-cn_journal-pharmaceutical-analysis_thesis/0201290725752.html">Liquid chromatography-mass spectrometry method for the quantification of an anti-sclerostin monoclonal antibody in cynomolgus 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W.&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Zularisam A. W.,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Chua Gek Kee&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Chua Gek Kee,</a> <span>2015</span> </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：使用制备型天然聚丙烯酰胺凝胶电泳优化H-192细胞中表达的单克隆抗体的纯化</span> </p> </li> <li> <div> <b>12. </b><a class="enjiyixqcontent" href="/ntis-science-report_ad_thesis/020711254128.html">Mouse Monoclonal Antibody Specific for an Allotypic Determinant of the Igh(a) Allele of Murine IgM: Genetic and Functional Analysis of Igh-6a Epitopes Using Anti-IgM Monoclonal Antibodies.</a> <b>[R] </b> . <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Sieckmann, D. G.&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Sieckmann, D. G.,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext= Stall, A. M.&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> Stall, A. M.,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext= Subbarao, B.&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> Subbarao, B. </a> <span>1991</span> </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：小鼠单克隆抗体特异性针对Igh（a）小鼠Igm等位基因的同种型决定因素：使用抗Igm单克隆抗体的Igh-6a表位的遗传和功能分析。</span> </p> </li> </ul> <ul style="display: none;"> <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/academic-journal-cn_china-chemical-express-english-version_thesis/0201292405006.html">SYNTHESIS OF INTERFERON-α_A MONOCLONAL ANTIBODY PACKING MATERIAL IN HIGH-PERFORMANCE AFFINITY CHROMATOGRAPHY AND PURIFICATION OF RECOMBINANT HUMAN INTERFERON-α_A</a> <b>[J]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Wen Ke FENG Xin Du GENG Laboratory of Modern Separation Science Department of Chemistry Northwest University Xi’an 710069&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . Wen Ke FENG Xin Du GENG Laboratory of Modern Separation Science Department of Chemistry Northwest University Xi’an 710069</a> <span> <a href="/journal-cn-52847/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 中国化学快报：英文版 </a> </span> <span> . 1991</span><span>,第5期</span> </span> </div> </li> <li> <div> <b>2. </b><a class="enjiyixqcontent" href="/academic-conference-cn_meeting-19543_thesis/020222239644.html">Preparative isolation of imperatorin, oxypeucedanin and isoimperatorin from a traditional Chinese herb using a high-speed countercurrent chromatography strategy based on optimization of rapid floWrate</a> <b>[C]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Yun Wei&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . Yun Wei</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Qianqian Xie&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,Qianqian Xie</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Derek Fisher&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,Derek Fisher</a> <span> <a href="/conference-cn-19543/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 第五届全国化工年会 </a> <span> <span> . 2008</span> </span> </div> </li> <li> <div> <b>3. </b><a class="enjiyixqcontent" href="/academic-degree-domestic_mphd_thesis/020315929588.html">High Capacity Temperature-responsive Affinity Chromatography Designed for Antibody Separation</a> <b>[A] </b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Mujeeb Ur Rahman&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . Mujeeb Ur Rahman</a> <span> . 2020</span> </span> </div> </li> </ul> <ul style="display: none;"> <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/patent-detail/06130403951907.html">monoclonal antibody, polynucleotide, light chain variable region, heavy chain variable region, composition, mixture, methods for producing an antibody, for preparing a pharmaceutical composition or mixture, for diagnosing an amyloid-associated disease or condition, to determine the degree of amyloidogenic plaque burden on a tissue to diagnose a predisposition to a disease or condition, to monitor minimal residual disease and to predict patient liability, use of a monoclonal antibody and / or a functional part thereof and / or a pharmaceutical composition or a mixture, hybridoma cell line, and test kits</a> <b>[P]</b> . <span> 外国专利：  BRPI0619748A8 </span> <span> . 2019-01-15</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：单克隆抗体，多核苷酸，轻链可变区，重链可变区，组成，混合物，制备抗体的方法，制备药物组合物或混合物的方法，用于诊断与淀粉样蛋白相关的疾病或状况，以确定淀粉样蛋白斑块的程度负担以诊断某种疾病或病状的易感性，监测最少的残留疾病并预测患者的责任，使用单克隆抗体和/或其功能部分和/或药物组合物或混合物，杂交瘤细胞系和测试套件 </span> </p> </li> <li> <div> <b>2. </b><a class="enjiyixqcontent" href="/patent-detail/06130425478678.html">monoclonal antibody, polynucleotide, light chain variable region, heavy chain variable region, composition, mixture, methods for producing an antibody, for preparing a pharmaceutical composition or mixture, for diagnosing an amyloid-associated disease or condition, to determine the degree of amyloidogenic plaque burden on a tissue, to diagnose a predisposition to a disease or condition, to minimally monitor residual disease and to predict a patient's liability, use of a monoclonal antibody and / or a functional part thereof and / or a pharmaceutical composition or a mixture, hybridoma cell line, and test kit</a> <b>[P]</b> . <span> 外国专利：  BRPI0619748A2 </span> <span> . 2011-10-18</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：单克隆抗体，多核苷酸，轻链可变区，重链可变区，组成，混合物，制备抗体的方法，制备药物组合物或混合物的方法，用于诊断与淀粉样蛋白相关的疾病或状况，以确定淀粉样蛋白斑块的程度组织负担，诊断疾病或病症的诱因，最小程度地监测残留疾病并预测患者的责任，使用单克隆抗体和/或其功能性部分和/或药物组合物或混合物，杂交瘤细胞系和测试套件 </span> </p> </li> <li> <div> <b>3. </b><a class="enjiyixqcontent" href="/patent-detail/06130451849085.html">METHOD OF PREPARING SURFACE ANTIGEN OF HEPATITIS B VIRUS (HBS AG), MONOCLONAL ANTIBODIES CB-HEPI, SURFACE ANTIGEN OF HEPATITIS B VIRUS (HBS AG) AND METHOD OF PREPARING HYBRID CLONE 48/1/574 PRODUCING MONOCLONAL ANTIBODIES CB-HEPI</a> <b>[P]</b> . <span> 外国专利：  RU2128707C1 </span> <span> . 1999-04-10</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：乙型肝炎病毒表面抗原（HBS AG），单克隆抗体CB-HEPI，乙型肝炎病毒表面抗原（HBS AG）的制备及制备单克隆抗体48/1/574的单克隆抗体 </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('0704028287922','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"> <h2>期刊订阅</h2> <img src="https://cdn.zhangqiaokeyan.com/img/loginclose.png" alt="" onclick="$('.journalsub-pop-up').hide()"> <p class="pardon">抱歉，该期刊暂不可订阅，敬请期待！</p> <p class="current">目前支持订阅全部北京大学中文核心（2020）期刊目录。</p> <div style="display: flex;margin-top: 69px;justify-content: space-between;"> <div class="no-sub" 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