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class="cat-81" href="https://www.technewschina.cn/category/tech-questions-and-answers/">科技问答</a> - </span> <span class="meta-date-info"> <span class="date meta-item"><span>三月 26, 2020</span></span> </span> </div> <div class="bdaia-post-title"> <h1 class="post-title entry-title">生物制药工艺流程有没有个标准？</h1> </div> <div class="article-meta-info"><div class="bd-alignleft"><span class="meta-author-avatar"><a href="https://www.technewschina.cn/author/amy/"><img alt='' src='https://secure.gravatar.com/avatar/c5991033cf3fd090ec7b02da39f3f037?s=140&d=mm&r=g' srcset='https://secure.gravatar.com/avatar/c5991033cf3fd090ec7b02da39f3f037?s=280&d=mm&r=g 2x' class='avatar avatar-140 photo' height='140' width='140' /></a></span><span class="meta-author meta-item"><a href="https://www.technewschina.cn/author/amy/" class="author-name" title="TechNewsChina中国科技新闻网">TechNewsChina中国科技新闻网</a></span><span class="meta-author-email meta-item"><a href="mailto:amy.yan@matchexpo.com" target="_blank"><span class="bdaia-io bdaia-io-envelop" ></span><span class="screen-reader-text"></span></a></span><span class="date meta-item"><span class="bdaia-io bdaia-io-clock" ></span> <span>三月 26, 2020</span></span></div><div class="bd-alignright"><span class="meta-comment meta-item"><a href="https://www.technewschina.cn/bioprocess-development-engineering-regulatory-compliance%e7%94%9f%e7%89%a9%e5%88%b6%e8%8d%af%e5%b7%a5%e8%89%ba%e6%b5%81%e7%a8%8b/#respond"><span class="fa fa-comments" ></span> 0</a></span><span class="views meta-item hot"><span class="bdaia-io bdaia-io-flame" ></span> <span>3,315</span></span><span class="reading-time meta-item"><span class="fa fa-bookmark" ></span> <span>6 second read </span></span></div><div class="cfix"></div></div> </header> <div class="bdaia-post-content"> <p>总的标准没有，但每个具体工艺有具体的标准。<a href="https://www.sartorius.com.cn/services/bioprocess-development-engineering" target="_blank" rel="noreferrer noopener" aria-label="生物制药（在新窗口打开）">生物制药</a>根据不同的工艺路线都会有不同的工艺流程;</p> <p>比如赛多利斯的集成解决方案项目团队从概念设计到最终现场验收，共有六大实施步骤。（第1步工艺优化——第2步：工艺建模——第3步：概念设计——第4步：基础工程设计——第5步：详细工程设计——第6步：项目执行);在完成工艺设计和详细工程设计后，赛多利斯的认证团队将组装完整的生物工艺设备，并在设施中进行全面的硬件、湿件（一次性系统）和软件检测。</p> <p>IQ/OQ 以及 PQ 是证明功能和性能的必要条件。检测计划经联合确定，获得了具有里程碑意义的“FAT 批准”。所有必需的检测将在发货和调试后，在 SAT 期间完成。</p> <p>为了确保在早期工艺阶段中实施的技术满足未来的法规要求，会仔细跟踪不断变化的行业监管要求，赛多利斯的专家也会积极参与标准组织（ASTM、ASME BPE、USP等），致力于制定面向未来的<a href="https://www.sartorius.com.cn/services/bioprocess-development-engineering/conceptual-design/regulatory-compliance" target="_blank" rel="noreferrer noopener" aria-label="一次性技术检测（在新窗口打开）">一次性技术检测</a>标准。一次性用品的现行标准（已与标准组织一起采用草案格式）包括：可提取物、颗粒、完整性测试和细胞生长。</p> </div> <script 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