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class="breadcrumb wow fadeInUp" data-wow-delay="0.8s"> <li class="breadcrumb-item"><a href="index.html">Home</a></li> <li class="breadcrumb-item">工艺及分析方法开发</li> </ol> </div> </div> </div> </div> <div id="services" class="servicess"> <!-- 导航 --> <div class="menubar"> <div class="hamburger"> <button type="button" class="lines-button"> <span class="lines"></span> </button> </div> </div> <div class="drawer"> <div class="menu-menu-engels-container"> <ul class="menu-menu-engels"> <li class="menu-item"><a href="service-35.html" class="link">Cell Line Development & Cell Bank Creation</a></li> <li class="menu-item"><a href="service-36.html" class="link">Process and Analytical Methods Development</a></li> <li class="menu-item"><a href="service-37.html" class="link">GMP Manufacturing</a></li> <li class="menu-item"><a href="service-38.html" class="link">Process Validation</a></li> </ul> </div> </div> <!-- 内容 --> <div class="servicesMain"> <div class="services_container"> <div class="w_title wow fadeInUp" data-wow-delay="0.7s">工艺及分析方法开发</div> <!-- --> <div class="services_title">细胞培养工艺开发</div> <div class="services_text"> <p> 安腾瑞霖细胞培养工艺开发平台基于质量源于设计（QbD）的理念，持续优化克隆筛选、培养基筛选、接种密度、补料策略和反应器控制策略等，在实现产量最大化和质量精确调控的同时，兼顾工艺稳定性和可放大性。上游工艺开发团队除了精通Fed batch工艺开发，还拥有多年强化工艺（高密度接种，高密度培养）和连续流（灌流）工艺开发经验。 </p> <br /> <ul> <li> 单抗Fed batch工艺产量 可达6-10 g/L （12-15天） </li> <li> 强化灌流工艺产量 最高达120 g/L （24天） </li> </ul> <br /> <table> <tbody> <tr> <th> 候选克隆 & 培养基筛选 </th> <td> <ul> <li> 与CLD同步开展，缩短开发时间 </li> <li> 进口/国产培养基筛选（Amber250,摇瓶） </li> </ul> </td> </tr> <tr> <th> 候选克隆 & 培养基确认 </th> <td> <ul> <li> 3 L生物反应器 </li> <li> Top1- 2克隆，基础培养基，补料培养基 </li> </ul> </td> </tr> <tr> <th> 工艺开发/确认 </th> <td> <ul> <li> 3 L生物反应器工艺开发 </li> <li> 关键参数（pH, 温度, 补料策略, 接种密度等） </li> </ul> </td> </tr> <tr> <th> 规模放大 </th> <td> <ul> <li> 3L 放大到10/200 L/500L/2000L规模 </li> <li> 技术转移 </li> </ul> </td> </tr> </tbody> </table> </div> <hr /> <div class="services_title">纯化工艺开发</div> <div class="services_text"> <p> 安腾瑞霖下游纯化团队具有丰富的项目开发经验，可以根据客户的产品特性，定制化设计纯化流程，确保在高回收率的前提下满足项目纯度要求，达到快速的工艺交付。 </p> <br /> <ul> <li> 纯化工艺开发平台典型抗体， 2-3个月即可获得稳定及可放大的工艺 </li> <li> 丰富的、多品种国际申报的病毒清除验证项目经验 </li> <li> 蛋白纯化工艺开发平均回收率为70%(包括单抗、双抗、类似药、创新药） </li> </ul> <p> <br /> </p> <img src="/upload/202209/07/202209071004275103.png" alt="" /><br /> </div> <hr /> <div class="services_title">处方及工艺开发</div> <div class="services_text"> <p> 安腾瑞霖制剂开发团队拥有丰富的单克隆抗体、双特异性抗体、融合蛋白、ADC等液体和冻干粉剂型的研发经验，可为生物药提供全面、快速的制剂开发，并提供稳健的处方和可放大的制剂工艺。 </p> <br /> <ul> <li> 具备完善的成药性研究能力，可基于氨基酸序列和结构建模，采用CADD和AIDD等工具，对候选分子进行可开发性评估和优化，同时在已经建立的高通量实验平台上进行验证和筛选，提高CMC开发成功率 </li> <li> 具有完备的制剂研究平台，可支持单抗、双抗、抗体片段、融合蛋白和ADC等分子的制剂开发 </li> <li> 具有高浓度制剂开发能力及完备的颗粒鉴定能力 </li> </ul> <br /> <div class="row"> <div class="col-md-3 col-6"> <p> <img src="/upload/202208/21/202208211229063320.jpg" alt="" /> </p> <p class="text-center"> MFI </p> </div> <div class="col-md-3 col-6"> <p> <img src="/upload/202208/21/202208211229190366.jpg" alt="" /> </p> <p class="text-center"> Uncle </p> </div> <div class="col-md-3 col-6"> <p> <img src="/upload/202208/21/202208211229299387.jpg" alt="" /> </p> <p class="text-center"> HIAC </p> </div> <div class="col-md-3 col-6"> <p> <img src="/upload/202208/21/202208211229413398.jpg" alt="" /> </p> <p class="text-center"> DSC </p> </div> </div> </div> <hr /> <div class="services_title">分析方法开发</div> <div class="services_text"> <p> 安腾瑞霖分析科学团队拥有丰富的单克隆抗体、双特异性抗体、融合蛋白、ADC等产品的分析表征经验，曾参与20余个IND项目和5个NDA/BLA项目的申报，具有丰富的产品结构鉴定、相似性和可比性研究经验，可提供贯穿生物药产品研发生产和申报周期的全面分析检测服务。 </p> <p> <br /> </p> <div class="ul_bg"> <div class="row"> <div class="col-md-4"> <ul> <li> CMC分析支持 </li> <li> 分析方法开发、验证及转移 </li> <li> 参比品鉴定 </li> </ul> </div> <div class="col-md-4"> <ul> <li> 产品中控及批放行 </li> <li> 稳定性研究 </li> <li> 结构表征 </li> </ul> </div> <p> <br /> </p> <ul> <li> 可比性研究 </li> <li> 相似性研究 </li> <li> PC/PV分析支持 </li> <li> E/L </li> </ul> </div> </div> <p> <br /> </p> <ul> <li> 具有支持不同阶段工艺可比性研究的能力，包括临床早期、NDA/BLA申报及上市后各阶段的工艺可比性 </li> <li> 具有全面的相似性研究能力，可满足中美欧要求的IND和NDA/BLA申报 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