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Development of a rapid and reliable analytical method for screening poloxamer 188 for use in cell culture process

机译：用于筛选泊洛沙姆188的快速可靠分析方法，用于细胞培养方法

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Abstract >Poloxamer P188 is a common nonionic surfactant additive used in cell culture media as a cellular protectant from the hydrodynamic forces and shear stress during bioprocessing. Presence of a hydrophobic high molecular weight impurity contaminant has been shown to compromise its protective properties and lead to batch failure. In this work we present, a reliable, sensitive, and rapid analytical method to detect and quantify the contaminant impurity in poloxamer 188. This method replaces a laborious and time‐consuming functional test in the form of a shake flask assay. The method is based upon reversed‐phase liquid chromatography with charged aerosol detection, simple mobile phase compositions, and a three‐step gradient. The method was optimized to resolve the impurity from the main P188 fraction in less than 10 min. Analytical method qualification and functional test comparison demonstrate equivalent or better high throughput impurity screening performance. Attempts to identify the impurity and establish suitable method positive control standards are also discussed. </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> > POLOXAMER P188是在细胞培养基中使用的普通非离子表面活性剂添加剂，作为从流体动力学力和生物处理期间的剪切应力的细胞保护剂。已显示疏水性高分子量杂质污染物的存在损害其保护性能并导致批量衰竭。在这项工作中，我们存在，可靠，敏感，快速的分析方法来检测和量化泊洛昔体188中的污染物杂质。该方法以摇动烧瓶测定的形式取代了艰苦的耗时的功能试验。该方法基于反相液相色谱，带有带电气溶胶检测，简单的流动相组合物和三步梯度。优化该方法以在小于10分钟内从主P188分解的杂质。分析方法资格和功能测试比较展示了等同或更好的高吞吐量筛选性能。还讨论了识别杂质并建立合适的方法阳性控制标准的试图。</ 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3期</span><b style="margin: 0 2px;">|</b><span>共6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=Bareford Lisa&option=202" target="_blank" rel="nofollow">Bareford Lisa;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Peng Haofan&option=202" target="_blank" rel="nofollow">Peng Haofan;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Ali Amr&option=202" target="_blank" rel="nofollow">Ali Amr;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Kolwyck David&option=202" target="_blank" rel="nofollow">Kolwyck David;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Dickens Jason&option=202" target="_blank" rel="nofollow">Dickens Jason;</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>Materials ScienceBiogenDavis North Carolina;</p> <p>Manufacturing SciencesBiogenDavis North Carolina;</p> <p>Analytical DevelopmentBiogenCambridge Massachusetts;</p> <p>Materials ScienceBiogenDavis North Carolina;</p> <p>Materials ScienceBiogenDavis North Carolina;</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=charged aerosol detector&option=203" rel="nofollow">charged aerosol detector;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=impurity&option=203" rel="nofollow">impurity;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=mammalian cell culture&option=203" rel="nofollow">mammalian cell culture;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=poloxamer 188&option=203" rel="nofollow">poloxamer 188;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=surfactant&option=203" rel="nofollow">surfactant;</a> </p> <div class="translation"> 机译：带电的气溶胶探测器;杂质;哺乳动物细胞培养;泊洛昔尔米蛋白剂188;表面活性剂; </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_frontiers-chemical-science-engineering-english_thesis/0201229199848.html">Real time monitoring of bioreactor mAb IgG3 cell culture process dynamics via Fourier transform infrared spectroscopy： Implications for enabling cell culture process analytical technology</a> <b>[J]</b> . <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Huiquan Wu12&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Huiquan Wu12,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Erik Read3&option=202" target="_blank" rel="nofollow" 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Jadhav</a> <span> <a href="/journal-cn-56200/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 美国分析化学（英文） </a> </span> <span> . 2017</span><span>,第6期</span> </span> </div> </li> <li> <div> <b>4. </b><a class="enjiyixqcontent" href="/academic-conference-cn_meeting-27875_thesis/020221907948.html">Photoconductance decay method using to monitor standard buried contact solar cell process</a> <b>[C]</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> <a href="/conference-cn-27875/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 第八届全国光伏会议暨中日光伏论坛 </a> <span> <span> . 2004</span> </span> </div> </li> </ul> <ul style="display: none;"> <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/patent-detail/06130415141064.html">Composition of adipose tissue or cells and poloxamer p188 for use in transplanting adipose tissue or cells</a> <b>[P]</b> . <span> 外国专利：  IL212471A </span> <span> . 2015-05-31</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：脂肪组织或细胞的组合物和泊洛沙姆p188，用于移植脂肪组织或细胞 </span> </p> </li> <li> <div> <b>2. </b><a class="enjiyixqcontent" href="/patent-detail/06130402108281.html">Human mesenchymal stem cell quality evaluation method, isolation, screening and culture method of human mesenchymal stem cell and cell population of rapidly growing human mesenchymal stem cell</a> <b>[P]</b> . <span> 外国专利：  JPWO2016017795A6 </span> <span> . 2019-11-28</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：人间充质干细胞质量评价方法，人间充质干细胞的分离，筛选和培养方法以及快速生长的人间充质干细胞的细胞群 </span> </p> </li> <li> <div> <b>3. </b><a class="enjiyixqcontent" href="/patent-detail/06130420686301.html">Method of preventing fat graft resorption by administering fat-derived cells and poloxamer P 188</a> <b>[P]</b> . <span> 外国专利：  US8512695B2 </span> <span> . 2013-08-20</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：通过施用脂肪来源的细胞和泊洛沙姆P 188来防止脂肪移植物再吸收的方法 </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('0704028287917','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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