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High throughput screening of ultrafiltration and diafiltration processing of monoclonal antibodies via the ambr? crossflow system

机译：通过AMBR，单克隆抗体的超滤和渗滤处理的高通量筛选？ 横流系统

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Abstract > As the biopharmaceutical industry moves toward high concentration of monoclonal antibody drug substance, additional development is required early on when material is still limited. A key constraint is the availability of predictive high‐throughput low‐volume filtration screening systems for bioprocess development. This particularly impacts final stages such as ultrafiltration/diafiltration steps where traditional scale‐down systems need hundreds of milliliters of material per run. Recently, the ambr? crossflow system has been commercialized by Sartorius Stedim Biotech (SSB) to meet this need. It enables parallel high throughput experimentation by only using a fraction of typical material requirements. Critical parameters for predictive filtration systems include loading, mean transmembrane pressure (Δ <mat:math display="inline" overflow="scroll" altimg="urn:x-wiley:87567938:media:btpr2929:btpr2929-math-0002" wiley:location="equation/btpr2929-math-0002.png"> <mat:mover> <mat:mi>P</mat:mi> <mat:mo>ˉ</mat:mo> </mat:mover> </mat:math> <sub>TMP</sub> ), and crossflow rate ( Q <sub>F</sub> ). While axial pressure drop (Δ P <sub>axial</sub> ) across the cartridge is a function of these parameters, it plays a key role and similar values should result across scales. The ambr? crossflow system is first presented describing typical screening experiments. Its performance is then compared to a traditional pilot‐scale tangential flow filtration (TFF) at defined conditions. The original ambr? crossflow (CF) cartridge underperformed resulting in ~20x lower Δ P <sub>axial</sub> than the pilot‐scale TFF flat‐sheet cassette. With an objective to improve the scalability of the system, efforts were made to understand this scale difference. The ambr? CF cartridge was successfully modified by restricting the flow of the feed channel, and thus increasing its Δ P <sub>axial</sub> . Additional studies across a range of loading (100–823?gm ?2 ); Δ <mat:math display="inline" overflow="scroll" altimg="urn:x-wiley:87567938:media:btpr2929:btpr2929-math-0003" wiley:location="equation/btpr2929-math-0003.png"> <mat:mover> <mat:mi>P</mat:mi> <mat:mo>ˉ</mat:mo> </mat:mover> </mat:math> <sub>TMP</sub> (12–18?psi); and Q <sub>F</sub> (4–8 L/min/m 2 ) were conducted in both scales. Comparable flux and aggregate levels were achieved. </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> > 随着生物制药业朝着高浓度的单克隆抗体药物迁移，当材料仍然有限时，需要提前提前开发。关键约束是用于生物过程开发的预测高通量低容量过滤筛选系统的可用性。这特别地影响了最终阶段，例如超滤/渗滤步骤，其中传统的缩放系统每次运行需要数百毫升的材料。最近，AMBR？ Sartorius Stedim Biotech（SSB）商业化的Crossflow系统以满足这种需求。它仅通过使用典型材料的一小部分来实现并行高通量实验。预测过滤系统的关键参数包括加载，平均跨膜压力（δ <mat：数学显示=“内联”overflow =“滚动”altimg =“urn：x-wiley：87567938：媒体：btpr2929：btpr2929-math-0002”wiley：location =“等式/ btpr2929-math-0002.png” > <MAT：MOVER> <MAT：MI> P </ MAT：MI> <mat：mo>ˉ</ mat：mo> </ mat：移动器> </ mat：math> <sub> tmp </ sub> ）和横流速率（ q </ i> <sub> f </ sub> ）。轴向压降（δ p </ i> <sub>轴向</ sub> ）在整个盒式盒上是这些参数的函数，它扮演一个关键角色，类似的值应该横跨比例。 AMBR？首先介绍横流系统描述典型的筛选实验。然后将其性能与在定义的条件下传统的导频级切向流过滤（TFF）进行比较。原来的ambr？ Crossflow（CF）墨盒表现不佳，导致Δ下降〜20x p </ i> <sub>轴向</ sub> 比飞行员规模的TFF平板盒式纸盒。目的是提高系统的可扩展性，努力了解这种比例差异。 AMBR？通过限制进料通道的流动成功修改CF盒，从而增加其δ p </ i> <sub>轴向</ sub> 。一系列载荷（100-823？GM ？2 </ sup> ）; δ. <mat：数学显示=“内联”overflow =“滚动”altimg =“urn：X-Wiley：87567938：媒体：BTPR2929：BTPR2929-Math-0003”Wiley：Location =“等式/ BTPR2929-Math-0003.png” > <MAT：MOVER> <MAT：MI> P </ MAT：MI> <mat：mo>ˉ</ mat：mo> </ mat：移动器> </ mat：math> <sub> tmp </ sub> （12-18？PSI）;和 q </ i> <sub> f </ sub> （4-8 L / min / m 2 </ sup> ）在两种尺度中进行。达到了可比的助焊剂和骨料水平。 </ 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>2020年第2期</span><b style="margin: 0 2px;">|</b><span>共10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=Fernandez‐Cerezo Lara&option=202" target="_blank" rel="nofollow">Fernandez‐Cerezo Lara;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Wismer Michael K.&option=202" target="_blank" rel="nofollow">Wismer Michael K.;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Han InKwan&option=202" target="_blank" rel="nofollow">Han InKwan;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Pollard Jennifer M.&option=202" target="_blank" rel="nofollow">Pollard Jennifer M.;</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>Downstream Process Development &</p> <p>EngineeringMerck &</p> <p>Co. IncKenilworth New Jersey;</p> <p>Scientific Engineering &</p> <p>DesignMerck &</p> <p>Co. IncKenilworth New Jersey;</p> <p>Downstream Process Development &</p> <p>EngineeringMerck &</p> <p>Co. IncKenilworth New Jersey;</p> <p>Downstream Process Development &</p> <p>EngineeringMerck &</p> <p>Co. IncKenilworth New Jersey;</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=ambr? crossflow&option=203" rel="nofollow">ambr? crossflow;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=high throughput screening&option=203" rel="nofollow">high throughput screening;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=monoclonal antibody processing&option=203" rel="nofollow">monoclonal antibody processing;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=tangential flow filtration&option=203" rel="nofollow">tangential flow filtration;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=ultrafiltration/diafiltration&option=203" rel="nofollow">ultrafiltration/diafiltration;</a> </p> <div class="translation"> 机译：AMBR？ 横流;高通量筛选;单克隆抗体加工;切向流过滤;超滤/渗滤; </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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M. E. Rayat&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Andrea C. M. E. Rayat,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Alex Chatel&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Alex Chatel,</a> <span>2019</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：用超滤膜研究在切向流过滤期间单克隆抗体处理的超缝线抗体处理</span> </p> </li> <li> <div> <b>10. </b><a class="enjiyixqcontent" href="/ntis-science-report_de_thesis/02071615969.html">Antibody/antigen detection system with application to high throughput identification and screening. Final report</a> <b>[R] </b> . <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> </a> <span>1996</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：抗体/抗原检测系统，适用于高通量鉴定和筛选。总结报告</span> </p> </li> </ul> <ul style="display: none;"> <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/academic-journal-cn_journal-hydrodynamics_thesis/0201276746829.html">MODELING ON DYNAMIC PROCESS OF MEMBRANE FOULING DURING FINITE CROSSFLOW ULTRAFILTRATION IN CHARGED SYSTEM</a> <b>[J]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=LUO Ming-Liang&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . LUO Ming-Liang</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=PU Chun-sheng&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,PU Chun-sheng</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=ZHAO Jian-qing&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,ZHAO Jian-qing</a> <span> <a href="/journal-cn-54991/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 水动力学研究与进展B辑 </a> </span> <span> . 2006</span><span>,第002期</span> </span> </div> </li> <li> <div> <b>2. </b><a class="enjiyixqcontent" href="/academic-journal-cn_science-china-information-sciences_thesis/0201258325498.html">High throughput monoclonal antibody generation by immunizing multiple antigens</a> <b>[J]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=LIU Ying&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . LIU Ying</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=WANG YunDan&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,WANG YunDan</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=LIU Jing&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,LIU Jing</a> <span> <a href="/journal-cn-17558/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 中国科学 </a> </span> <span> . 2014</span><span>,第007期</span> </span> </div> </li> <li> <div> <b>3. </b><a class="enjiyixqcontent" href="/academic-journal-cn_insight-sport-science_thesis/0201273806008.html">Screening of anti-human albumin monoclonal antibody by chemiluminescence immunoassay</a> <b>[J]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Hongliang Wen1&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . Hongliang Wen1</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Danyang Li1&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,Danyang Li1</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Yuzhan Wu1&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,Yuzhan Wu1</a> <span> <a href="/journal-cn-55783/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 洞察-体育科学 </a> </span> <span> . 2019</span><span>,第001期</span> </span> </div> </li> </ul> <ul style="display: none;"> <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/patent-detail/06130432836191.html">method of effecting prophylaxis or treating a disease, pharmaceutical composition, monoclonal antibody, hybridoma cell, and method of screening an agent, humanizing monoclonal antibody 8a5 or monoclonal antibody 6h7 and producing a chimeric form of monoclonal antibody 8a5 or monoclonal antibody 6h7</a> <b>[P]</b> . <span> 外国专利： <!-- --> BRPI0514199A </span> <span> . 2008-06-03</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：预防或治疗疾病的方法，药物组合物，单克隆抗体，杂交瘤细胞以及筛选药物的方法，将单克隆抗体8a5或单克隆抗体6h7人源化并产生单克隆抗体8a5或单克隆抗体6h7的嵌合形式 </span> </p> </li> <li> <div> <b>2. </b><a class="enjiyixqcontent" href="/patent-detail/06130440115835.html">Capillary electrophoretic analysis method, monoclonal protein screening and typing methods, modified antibody preparation process, modified antibodies, monoclonal protein detection and typing kit, and antibody use</a> <b>[P]</b> . <span> 外国专利： <!-- --> BRPI0406265A </span> <span> . 2005-08-23</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：毛细管电泳分析方法，单克隆蛋白筛选和分型方法，修饰的抗体制备过程，修饰的抗体，单克隆蛋白检测和分型试剂盒以及抗体使用 </span> </p> </li> <li> <div> <b>3. </b><a class="enjiyixqcontent" href="/patent-detail/06130501367558.html">HIGH THROUGHPUT SCREENING FOR MONOCLONAL ANTIBODY PAIRS</a> <b>[P]</b> . <span> 外国专利： <!-- --> WO2022010736A1 </span> <span> . 2022-01-13</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：单克隆抗体对的高通量筛选 </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('0704028287883','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" 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