生物反应器生产
![Bioreactor Production 上游生产](/deepweb/assets/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/monoclonal-antibody-manufacturing/bioreactor-production/bioreactor-production.jpg)
不锈钢装置通常成本高昂且费时。相反,采用一次性或混合系统则是一条更快、更灵活且资本消耗更少的途径。选择一次性生物反应器平台时,主要考虑因素包括可扩展性和质量控制:
- 为了成功实施大规模的一次性生物反应器平台,必须证明整个平台与较小尺寸的生物反应器具有同等的性能或可扩展性。同时需要对关键工程参数进行表征,包括每体积的功率输入、混合时间、氧气传输能力以及对所有规模的温度测试。
- 为了使一次性产品和系统达到高质量标准,必须建立成熟的质量控制系统。该系统需要管理整个生命周期,包括从组件选择、测试和鉴定到组装制造、过程中测试以及终产品发布。
支持技术内容
mAb表达、纯化和制剂
一次性上游套件的部署和质控
网络研讨会:
补料分批操作中一次性上游技术的实施
一次性系统生产过程中对供应商质量控制的审查
攻克一次性药品生产的质量和监管挑战
文章:一次性系统中的质量管理
管理上游套件的工艺扩展和技术转移
从中试到工艺规模的转换和技术的转移需要精确无缝的组织、沟通和文档编制。完善的技术转移包:
- 清晰地呈现对工艺和技术的说明
- 确定实现项目目标的适当途径
- 与ICH Q10中概述的药品质量管理体系保持一致
工作流程
![Upstream Strategy Upstream Strategy](/deepweb/assets/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/monoclonal-antibody-manufacturing/upstream-strategy/upstream-strategy.jpg)
![Cell Line Development Cell Line Development](/deepweb/assets/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/monoclonal-antibody-manufacturing/cell-line-development/cell-line-development.jpg)
细胞系开发
Development begins by selecting single-cell clones that can produce the biologic of interest, then screening for clones that are stable, productive, and scalable
![Media and Process Development Media and Process Development](/deepweb/assets/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/monoclonal-antibody-manufacturing/media-process-development/media-process-development.jpg)
培养基和工艺开发
Achieving consistent cell culture performance requires careful screening, selection, and optimization of media formulations and feed
![Monoclonal Antibody Manufacturing Monoclonal Antibody Manufacturing](/deepweb/assets/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/monoclonal-antibody-manufacturing/mAb-lab/mAb-lab.jpg)
单克隆抗体生产
Monoclonal antibody manufacturing is a highly templated approach used to produce mAb-based immunotherapies. Robust, scalable process solutions are required at every step to ensure high therapeutic concentration and process safety, while meeting speed-to-market and cost containment concerns.
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