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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">GMP生产</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">GMP生产</div> <!-- --> <div class="services_title">中试生产</div> <div class="services_text"> <p> <br /> </p> <p> 安腾瑞霖依托于复宏汉霖丰富的单抗、双抗、融合蛋白等项目的技术转移、临床生产和注册经验，可用更低的投入、更少的时间、更高的容错率帮助客户顺利完成生产工艺的中试放大、非临床和临床研究用药品的生产以及IND申报。 </p> <p> 采用一次性生产技术和不锈钢生产设备相结合的方式，安腾瑞霖已经形成了一套高效、稳定的生产平台。对于共用设备，通过有效的清洁程序和清洁监测评估，可减少不同产品共线生产的污染风险。 </p> <div> <ul> <li> 3条细胞培养生产线（200 L*2；500 L*2；200 L*1+500 L*1）一次性生物反应器；3条Fed-batch模式下游生产线和1条智能化连续生产线（灌流+下游连续）； </li> <li> 拥有西林瓶水针、冻干制剂能力，兼容2R~50R规格； </li> <li> 拥有20+临床申请项目技术转移经验，建立了从5 L到200 L/500 L放大模型； </li> <li> 中英双语，符合GMP文件体系要求的批生产记录； </li> <li> 拥有100+批 200 L&500 L 非临床批及临床批生产经验。 </li> </ul> </div> </div> <hr /> <div class="services_title">商业化生产</div> <div class="services_text"> <p> 复宏汉霖徐汇基地和松江基地（一）已投入商业化生产，现有商业化总产能已达48,000升，规划2026年公司总产能可达144,000升。复宏汉霖已于2019年启动建设第三个基地——松江基地（二），一期项目规划总产能96,000升，其中36,000升产能有望于2024年底正式投入商业化生产。 </p> <p> <br /> </p> <p> 复宏汉霖会根据产品的市场需求，合理分配和动态调整产能规划，持续探索优势产能和技术的最大化利用，计划在2024年底将徐汇基地24,000升产能用于安腾瑞霖商业化生产订单，以此进一步加速安腾瑞霖符合国际GMP标准的产能布局，赋能安腾瑞霖实现从早期临床生产至商业化生产的高效衔接，以成熟商业化生产经验的生产和质量团队，满足国内外客户需求，提升项目交付能力。 </p> <p style="text-align:center;"> <img src="/upload/202208/29/202208291156209311.jpg" alt="" width="500" height="333" title="" align="" /> <img src="/upload/202208/29/202208291156309790.jpg" alt="" width="500" height="333" title="" align="" /> </p> </div> <hr /> <div class="services_title">质量体系</div> <div class="services_text"> <p> 安腾瑞霖建立了贯穿研发到商业化生产的全生命周期质量体系，遵循“质量优先”的基本原则，参照主流市场（中国、EMA、US-FDA）的相关法律法规以及其它如WHO、ICH、PDA等药品研发生产的质量指南制定。面向多终端市场，以高标准满足客户药品上市需求。 </p> <br /> <p> 安腾瑞霖的质量策略是递进式的质量控制，在药品生产的不同阶段实施不同程度的cGMP的控制要求。从研发端开始实施一步步增强，在临床III期时完全遵守cGMP控制要求。递进式的质量控制实现了产品安全控制的同时，避免前期的过度质量成本投入，确保成本最优化。 </p> </div> </div> </div> </div> <!-- #BeginLibraryItem "/Footer.lbi" --> <meta http-equiv="Content-Type" content="text/html; charset=utf-8"> <!-- #BeginLibraryItem "/Footer.lbi" --> <footer> <div class="topIcon" 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