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Real‐time quantification and supplementation of bioreactor amino acids to prolong culture time and maintain antibody product quality

机译：生物反应器氨基酸的实时定量和补充延长培养时间并维持抗体产品质量

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Abstract >Real‐time monitoring of cell cultures in bioreactors can enable expedited responses necessary to correct potential batch failure perturbations which may normally go undiscovered until the completion of the batch and result in failure. Currently, analytical technologies are dedicated to real‐time monitoring of bioreactor parameters such as pH, dissolved oxygen, and temperature, nutrients such as glucose and glutamine, or metabolites such as lactate. Despite the importance of amino acids as the building blocks of therapeutic protein products, other than glutamine their concentrations are not commonly measured. Here, we present a study into amino acid monitoring, supplementation strategies, and how these techniques may impact the cell growth profiles and product quality. We used preliminary bioreactor runs to establish baselines by determining initial amino acid consumption patterns, the results of which were used to select a pool of amino acids which gets depleted in the bioreactor. These amino acids were combined into blends which were supplemented into bioreactors during a subsequent run, the concentrations of which were monitored using a mass spectrometry based at‐line method we developed to quickly assess amino acid concentrations from crude bioreactor media. We found that these blends could prolong culture life, reversing a viable cell density decrease that was leading to batch death. Additionally, we assessed how these strategies might impact protein product quality, such as the glycan profile. The amino acid consumption data were aligned with the final glycan profiles in principal component analysis to identify which amino acids are most closely associated with glycan outcomes. </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> >生物反应器中细胞培养物的实时监测可以使加速响应纠正可能通常未被发现的潜在批次失败扰动，直到批次完成并导致失败。目前，分析技术致力于实时监测生物反应器参数，例如pH，溶解的氧气和温度，葡萄糖和谷氨酸等营养素，或乳酸等代谢物。尽管氨基酸作为治疗蛋白质产品的构建块，但除了谷氨酰胺之外，它们的浓度通常不常见。在这里，我们向氨基酸监测，补充策略以及这些技术如何影响细胞生长谱和产品质量的研究。我们使用初步生物反应器通过确定初始氨基酸消耗模式来建立基线，其结果用于选择在生物反应器中耗尽的氨基酸池。将这些氨基酸组合成共混物，该共混物在随后的运行期间补充到生物反应器中，其浓度使用基于质谱法的浓度进行，我们开发出来以快速评估来自粗生物反应器介质的氨基酸浓度。我们发现这些混合物可以延长培养寿命，扭转了导致批量死亡的可行细胞密度降低。此外，我们还评估了这些策略如何影响蛋白质产品质量，例如甘草概况。氨基酸消耗数据与主要成分分析中的最终聚糖型材对齐，以鉴定哪些氨基酸与甘油结果最密切相关。</ 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6期</span><b style="margin: 0 2px;">|</b><span>共11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=Powers David N.&option=202" target="_blank" rel="nofollow">Powers David N.;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Wang Yifan&option=202" target="_blank" rel="nofollow">Wang Yifan;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Fratz‐Berilla Erica J.&option=202" target="_blank" rel="nofollow">Fratz‐Berilla Erica J.;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Velugula‐Yellela Sai Rashmika&option=202" target="_blank" rel="nofollow">Velugula‐Yellela Sai Rashmika;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Chavez Brittany&option=202" target="_blank" rel="nofollow">Chavez Brittany;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Angart Phillip&option=202" target="_blank" rel="nofollow">Angart Phillip;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Trunfio Nicholas&option=202" target="_blank" rel="nofollow">Trunfio Nicholas;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Yoon Seongkyu&option=202" target="_blank" rel="nofollow">Yoon Seongkyu;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Agarabi Cyrus&option=202" target="_blank" rel="nofollow">Agarabi Cyrus;</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>U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Product Quality Office of Biotechnology Products Division of Biotechnology Review and Research IISilver Spring Maryland;</p> <p>U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Testing and Research Division of Product Quality ResearchSilver Spring Maryland;</p> <p>U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Product Quality Office of Biotechnology Products Division of Biotechnology Review and Research IISilver Spring Maryland;</p> <p>U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Product Quality Office of Biotechnology Products Division of Biotechnology Review and Research IISilver Spring Maryland;</p> <p>U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Product Quality Office of Biotechnology Products Division of Biotechnology Review and Research IISilver Spring Maryland;</p> <p>U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Product Quality Office of Biotechnology Products Division of Biotechnology Review and Research IISilver Spring Maryland;</p> <p>U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Product Quality Office of Biotechnology Products Division of Biotechnology Review and Research IISilver Spring Maryland;</p> <p>Department of Chemical EngineeringUniversity of MassachusettsLowell Massachusetts;</p> <p>U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Product Quality Office of Biotechnology Products Division of Biotechnology Review and Research IISilver Spring Maryland;</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=amino acids&option=203" rel="nofollow">amino acids;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=bioprocessing&option=203" rel="nofollow">bioprocessing;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=glycosylation&option=203" rel="nofollow">glycosylation;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=MVDA&option=203" rel="nofollow">MVDA;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=PCA&option=203" rel="nofollow">PCA;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=process analytical technology&option=203" rel="nofollow">process analytical technology;</a> </p> <div class="translation"> 机译：氨基酸;生物加工;糖基化;MVDA;PCA;过程分析技术; </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="/journal-foreign-detail/0704021880212.html">Real‐time quantification and supplementation of bioreactor amino acids to prolong culture time and maintain 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R. </a> <span>1988</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：海水中溶解游离氨基酸和铵的实时检测</span> </p> </li> </ul> <ul style="display: none;"> <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/academic-journal-cn_journal-qiqihar-medical-university_thesis/0201279906170.html">延长肺泡灌洗液真菌培养时间确诊肺隐球菌病的2例报道</a> <b>[J]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=李小梦&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . 李小梦</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=蒋露晰&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,蒋露晰</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=李曦&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,李曦</a> <span> <a href="/journal-cn-6538/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 齐齐哈尔医学院学报 </a> </span> <span> . 2020</span><span>,第014期</span> </span> </div> </li> <li> <div> <b>2. </b><a class="enjiyixqcontent" href="/academic-journal-cn_detail_thesis/0201292899888.html">延长初发酵培养时间对大肠菌群检测结果的影响</a> <b>[J]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=谢爱春&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . 谢爱春</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=朱姝&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,朱姝</a> <span> <a href="/journal-cn-56983/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 中国卫生检验杂志 </a> </span> <span> . 2009</span><span>,第1期</span> </span> </div> </li> <li> <div> <b>3. </b><a class="enjiyixqcontent" href="/academic-journal-cn_detail_thesis/0201295340245.html">延长初发酵培养时间对大肠菌群检测结果的影响</a> <b>[J]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=谢爱春&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . 谢爱春</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=朱姝&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,朱姝</a> <span> <a href="/journal-cn-57089/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 实用预防医学 </a> </span> <span> . 2008</span><span>,第1期</span> </span> </div> </li> <li> <div> <b>4. </b><a class="enjiyixqcontent" href="/academic-journal-cn_administration-technique-environmental-monitoring_thesis/0201217800808.html">延长初发酵培养时间对大肠菌群结果影响分析</a> <b>[J]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=甄清&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . 甄清</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=李勇&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,李勇</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=王一东&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,王一东</a> <span> <a href="/journal-cn-9820/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 环境监测管理与技术 </a> </span> <span> . 2007</span><span>,第001期</span> </span> </div> </li> <li> <div> <b>5. </b><a class="enjiyixqcontent" href="/academic-journal-cn_detail_thesis/0201293936181.html">延长初发酵培养时间对各类样本大肠菌群结果影响分析</a> <b>[J]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=甄清&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . 甄清</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=刘雅文&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,刘雅文</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=李勇&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,李勇</a> <span> <a href="/journal-cn-56983/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 中国卫生检验杂志 </a> </span> <span> . 2007</span><span>,第5期</span> </span> </div> </li> <li> <div> <b>6. </b><a class="enjiyixqcontent" href="/academic-conference-cn_meeting-3896_thesis/02022901013.html">D-氨基酸的新见解——具有维持皮肤稳态及屏障恢复等功能的新型氨基酸群</a> <b>[C]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Yosuke Tojo&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . Yosuke Tojo</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=东条洋介&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,东条洋介</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Chieko Okamura&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,Chieko Okamura</a> <span> <a href="/conference-cn-3896/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 第十届中国化妆品学术研讨会 </a> <span> <span> . 2014</span> </span> </div> </li> <li> <div> <b>7. </b><a class="enjiyixqcontent" href="/academic-degree-domestic_mphd_thesis/020316244386.html">延长培养时间及术中采样前应用抗生素对人工关节感染病原菌培养结果的影响</a> <b>[A] </b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=张子杰&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . 张子杰</a> <span> . 2020</span> </span> </div> </li> </ul> <ul style="display: none;"> <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/patent-detail/06120112524795.html">一种延长秋海棠组培苗继代培养时间的方法</a> <b>[P]</b> . <span> 中国专利： CN112535102A </span> <span> . 2021-03-23</span> </div> </li> <li> <div> <b>2. </b><a class="enjiyixqcontent" href="/patent-detail/061201229767.html">作为抗血小板剂、营养补充剂和维生素补充剂的乙酰化氨基酸</a> <b>[P]</b> . <span> 中国专利： CN101505783B </span> <span> . 2013.09.04</span> </div> </li> <li> <div> <b>3. </b><a class="enjiyixqcontent" href="/patent-detail/06130417743843.html">METHODS FOR DETERMINING GENETIC OR PROTEIN / ENZYME MARKERS TO PROGNOSE THE EXPECTED VALUE OF A SPECIFIC QUALITY TRADE FOR AN AGRICULTURAL PRODUCT OR TO PROGNOSTIC THE EXPECTED VALUE OF A RESPECTIVE QUALITY FOR A RESPECTIVE QUALITY HORTICULTURE AND TO DETERMINE THE TIME DEPARTURE AND THE END POINT IN THE GREAT HARVEST TIME OF AN AGRICULTURAL OR HORTICULTURAL PRODUCT, GDSL, AND, ANTIBODY MARKER AND LIPASE USES.</a> <b>[P]</b> . <span> 外国专利： <!-- --> BRPI0807589A2 </span> <span> . 2014-07-01</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：确定基因或蛋白质/酶标记以预测农产品特定质量贸易的预期价值或预测特定质量预期质量的方法并确定时间并确定时间的方法农产品或园艺产品，GDSL以及抗体标记物和脂酶的巨大收成时间。 </span> </p> </li> <li> <div> <b>4. </b><a class="enjiyixqcontent" href="/patent-detail/06130416670572.html">Automatic realtime PCR system for the various analysis of biological sample, method for Automatic nucleic acid purification and realtime quantification of gene amplification, method for automatic viable cell count of pathogenic bacteria using realtime quantitative PCR, method for automatically getting antigene density using quantitative immunity PCR</a> <b>[P]</b> . <span> 外国专利： <!-- 韩国专利： --> KR101420094B1 </span> <span> . 2014-07-17</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：用于对生物样品进行各种分析的自动实时PCR系统，自动核酸纯化和基因扩增的实时定量方法，使用实时定量PCR进行病原菌自动活细胞计数的方法，使用定量免疫PCR自动获得抗原密度的方法 </span> </p> </li> <li> <div> <b>5. </b><a class="enjiyixqcontent" href="/patent-detail/06130422055878.html">AUTOMATIC REALTIME PCR SYSTEM FOR THE VARIOUS ANALYSIS OF BIOLOGICAL SAMPLE, METHOD FOR AUTOMATIC NUCLEIC ACID PURIFICATION AND REALTIME QUANTIFICATION OF GENE AMPLIFICATION, METHOD FOR AUTOMATIC VIABLE CELL COUNT OF PATHOGENIC BACTERIA USING REALTIME QUANTITATIVE PCR, METHOD FOR AUTOMATICALLY GETTING ANTIGENE DENSITY USING QUANTITATIVE IMMUNITY PCR</a> <b>[P]</b> . <span> 外国专利： <!-- 韩国专利： --> KR20120044197A </span> <span> . 2012-05-07</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：用于各种生物样品分析的自动实时PCR系统，自动核酸纯化和基因扩增的实时定量方法，利用实时定量PCR自动检测病原菌的活细胞数量的方法，用于定量自动定量抗原性的方法 </span> </p> </li> </ul> </div> </div> </div> <div class="theme cardcommon" style="overflow: 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