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Suitability of a generic virus safety evaluation for monoclonal antibody investigational new drug applications

机译：单克隆抗体调查新药物应用的通用病毒安全评估适用性

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Abstract >Biologics produced from CHO cell lines with endogenous virus DNA can produce retrovirus‐like particles in cell culture at high titers, and other adventitious viruses can find their way through raw materials into the process to make a product. Therefore, it is the industry standard to have controls to avoid introduction of viruses into the production process, to test for the presence of viral particles in unclarified cell culture, and to develop purification procedures to ensure that manufacturing processes are robust for viral clearance. Data have been accumulated over the past four decades on unit operations that can inactivate and clear adventitious virus and provide a high degree of assurance for patient safety. During clinical development, biological products are traditionally tested at process set points for viral clearance. However, the widespread implementation of platform production processes to produce highly similar IgG antibodies for many indications makes it possible to leverage historical data and knowledge from representative molecules to allow for better understanding and control of virus safety. More recently, individualized viral clearance studies are becoming the rate‐limiting step in getting new antibody molecules to clinic, particularly in Phase 0 and eIND situations. Here, we explore considerations for application of a generic platform virus clearance strategy that can be applied for relevant investigational antibodies within defined operational parameters in order to increase speed to the clinic and reduce validation costs while providing a better understanding and assurance of process virus safety. </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> >从Cho细胞系中产生的生物学，具有内源性病毒DNA可以在高滴度的细胞培养中产生逆转录病毒样颗粒，而其他偶毒病毒可以通过原材料探讨到制造产品的过程中。因此，它是行业标准，以避免将病毒引入生产过程中，以测试在无氧化细胞培养中存在病毒颗粒，并开发纯化程序，以确保制造过程对病毒间隙具有鲁棒性。在过去的四十年里，数据已经积累了可以对其灭活和清除不定毒性的单位操作，并为患者安全提供高度保证。在临床开发期间，生物产品在传统上在工艺设定点进行病毒间隙测试。然而，平台生产过程的广泛实施对于许多适应症产生高度相似的IgG抗体使得可以利用代表性分子利用历史数据和知识来允许更好地理解和控制病毒安全性。最近，个性化病毒清除研究正在成为使新抗体分子到临床的速率限制步骤，特别是在阶段0和EIND情况下。在这里，我们探讨应用通用平台病毒间隙策略的考虑，这些策略可以应用于确定的操作参数内的相关调查抗体，以便将速度提高到诊所并降低验证成本，同时提供更好的理解和保证过程病毒安全性。 </ 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=Sipple Patrick&option=202" target="_blank" rel="nofollow">Sipple Patrick;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Nguyen Tung&option=202" target="_blank" rel="nofollow">Nguyen Tung;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Patel Krina&option=202" target="_blank" rel="nofollow">Patel Krina;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Jaffe Neil&option=202" target="_blank" rel="nofollow">Jaffe Neil;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Chen Yan&option=202" target="_blank" rel="nofollow">Chen Yan;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Khetan Anurag&option=202" target="_blank" rel="nofollow">Khetan Anurag;</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>Product DevelopmentBristol‐Myers SquibbPrinceton New Jersey;</p> <p>Product DevelopmentBristol‐Myers SquibbPrinceton New Jersey;</p> <p>Product DevelopmentBristol‐Myers SquibbPrinceton New Jersey;</p> <p>Product DevelopmentBristol‐Myers SquibbPrinceton New Jersey;</p> <p>Product DevelopmentBristol‐Myers SquibbPrinceton New Jersey;</p> <p>Product DevelopmentBristol‐Myers SquibbPrinceton 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=bracketed viral clearance&option=203" rel="nofollow">bracketed viral clearance;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=generic viral clearance&option=203" rel="nofollow">generic viral clearance;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=investigational new drug application&option=203" rel="nofollow">investigational new drug application;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=modular viral clearance&option=203" rel="nofollow">modular viral clearance;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=monoclonal antibody safety&option=203" rel="nofollow">monoclonal antibody safety;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=speed to clinic&option=203" rel="nofollow">speed to clinic;</a> </p> <div class="translation"> 机译：括号的病毒间隙;通用病毒清除;调查新药物应用;模块化病毒间隙;单克隆抗体安全;速度诊所; </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-integrative-agriculture_thesis/020126227335.html">Monoclonal Antibodies Against the Whitefly-Transmitted Tomato Yellow Leaf Curl Virus and Their Application in Virus Detection</a> <b>[J]</b> . <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=WU Jian-xiang&option=202" target="_blank" rel="nofollow" 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</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：使用通用套件的方法定量抗体药物缀合物，曲妥珠单抗蛋白和单克隆抗体，曲妥珠单抗，血浆中的血浆</span> </p> </li> <li> <div> <b>10. </b><a class="enjiyixqcontent" href="/academic-degree-foreign_mphd_thesis/02061627286.html">Development of bispecific monoclonal antibodies and their applications in ultrasensitive virus ELISA; phage display technology and viral purification</a> <b>[D] </b> . <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Liu, Fei&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Liu, Fei </a> <span>1999</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：双特异性单克隆抗体的开发及其在超敏病毒ELISA中的应用；噬菌体展示技术和病毒纯化</span> </p> </li> <li> <div> <b>11. </b><a class="enjiyixqcontent" href="/academic-journal-foreign-pmc_detail_thesis/040004009367.html">Phase I Evaluation of the Safety and Pharmacokinetics of a Single-Dose Intravenous Injection of a Murine Monoclonal Antibody against Hantaan Virus in Healthy Volunteers</a> <b>[O] </b> . <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Rong Xu&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Rong Xu,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Xiao Yan Yang&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Xiao Yan Yang,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Dao Feng Yang&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Dao Feng Yang,</a> <span>2009</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：I期评估健康志愿者单剂量静脉注射抗汉坦病毒的鼠单克隆抗体的安全性和药代动力学</span> </p> </li> <li> <div> <b>12. </b><a class="enjiyixqcontent" href="/open-access_resources_thesis/0100037771746.html ">Phase I Evaluation of the Safety and Pharmacokinetics of a Single-Dose Intravenous Injection of a Murine Monoclonal Antibody against Hantaan Virus in Healthy Volunteers▿</a> <b>[O] </b> . <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Xu, Rong&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Xu, Rong,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Yang, Xiao Yan&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Yang, Xiao Yan,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Yang, Dao Feng&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Yang, Dao Feng,</a> <span>2009</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：在健康志愿者中单剂量静脉注射抗汉坦病毒的鼠单克隆抗体的单次剂量静脉注射的安全性和药代动力学▿</span> </p> </li> <li> <div> <b>13. </b><a class="enjiyixqcontent" href="/ntis-science-report_ad_thesis/02071159665.html">Delayed Treatment of Ebola Virus Infection with Plant-Derived Monoclonal Antibodies Provides Protection in Rhesus Macaques.</a> <b>[R] </b> . <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Olinger, J. G.&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">Olinger, J. G.,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext= Pettitt, J.&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> Pettitt, J.,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext= Kim, D.&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> Kim, D.,</a> <span>2012</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：用植物来源的单克隆抗体延迟治疗埃博拉病毒感染为恒河猴提供保护。</span> </p> </li> </ul> <ul style="display: none;"> <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/academic-conference-cn_meeting-9639_thesis/020222338696.html">An Application of Fuzzy Matter-Element Theory in Ecological Safety Evaluation of Tourism City</a> <b>[C]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Jiulong ZHU&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . Jiulong ZHU</a> <span> <a href="/conference-cn-9639/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 第三届国际信息技术与管理科学学术研讨会 </a> <span> <span> . 2011</span> </span> </div> </li> </ul> <ul style="display: none;"> <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/patent-detail/06130419265240.html">Monoclonal Antibodies APPLICATION FOR IDENTIFICATION OR YAMAGATSKOY Victorian evolutionary lineages of influenza virus type B. STRAIN 4N7 hybrids to produce monoclonal antibodies for certain viruses influenza YAMAGATSKOY branches. STRAIN hybrids / 4H1 For preparation of monoclonal antibodies for certain viruses Influenza Victorian BRANCH</a> <b>[P]</b> . <span> 外国专利：  RU2011127014A </span> <span> . 2013-01-10</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：单克隆抗体鉴定或YAMAGATSKOY的应用B型流感病毒的维多利亚州进化谱系。应变4N7杂种可为某些病毒YAMAGATSKOY分支产生单克隆抗体。 STRAIN hybrids / 4H1用于制备某些病毒的单克隆抗体维多利亚维多利亚分公司 </span> </p> </li> <li> <div> <b>2. </b><a class="enjiyixqcontent" href="/patent-detail/06130401882937.html">Method for neutralizing hepatitis C virus, fully human monoclonal antibody against hepatitis C virus (variants), composition of fully human monoclonal antibodies against hepatitis C virus and hybrid mouse/human producer cell line of fully human monoclonal antibodies against hepatitis C virus (variants)</a> <b>[P]</b> . <span> 外国专利：  US10633431B2 </span> <span> . 2020-04-28</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：中和丙型肝炎病毒的方法，抗丙型肝炎病毒的完全人类单克隆抗体（变体），抗丙型肝炎病毒的完全人类单克隆抗体的组成以及抗丙型肝炎病毒的完全人类单克隆抗体的杂种小鼠/人类生产细胞系（变体） </span> </p> </li> <li> <div> <b>3. </b><a class="enjiyixqcontent" href="/patent-detail/06130409973342.html">METHOD FOR NEUTRALIZING HEPATITIS C VIRUS, FULLY HUMAN MONOCLONAL ANTIBODY AGAINST HEPATITIS C VIRUS (VARIANTS), COMPOSITION OF FULLY HUMAN MONOCLONAL ANTIBODIES AGAINST HEPATITIS C VIRUS AND HYBRID MOUSE/HUMAN PRODUCER CELL LINE OF FULLY HUMAN MONOCLONAL ANTIBODIES AGAINST HEPATITIS C VIRUS (VARIANTS)</a> <b>[P]</b> . <span> 外国专利：  US2017121390A1 </span> <span> . 2017-05-04</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：中和肝炎病毒，针对人类丙型肝炎病毒的全人类单克隆抗体，变异型，针对人类丙型肝炎病毒/人禽流感病毒的混合型人单克隆抗体的方法 </span> </p> </li> </ul> </div> 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