生物反应器生产
不锈钢装置通常成本高昂，耗时长。相比之下，采用一次性使用或混合系统是一条更快、更灵活、资本密集度更低的途径。在选择一次性使用生物反应器平台时，主要的考虑因素包括可扩展性和质量控制：
- 要成功实施大规模一次性使用生物反应器平台，必须证明整个平台与较小尺寸的生物反应器具有同等性能或可扩展性。需要对所有规模的关键工程参数进行表征，包括单位体积的功率输入、混合时间、氧气传输能力和温度映射。
- 要使一次性使用产品和系统达到高质量标准，必须有一个成熟的质量控制系统。该系统需要管理整个生命周期，从组件选择、测试和鉴定，到装配制造、过程中测试和最终产品发布。
特色类别
管理上游成套装置的工艺放大和技术转让
从中试规模到工艺规模的转换和技术转让需要精确、无缝的组织、沟通和文档记录。A well-developed technology transfer package:
- Provides a clear understanding of the process and technologies
- Determines the appropriate path to achieve goals of the project
- Aligns with the pharmaceutical quality management system as outlined in ICH Q10
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相关产品资源
- Tech Brief: Mobius® Single-use Bioreactors: Platform Scalability
This brief discusses the characteristics and performance of Mobius® single-use bioreactors, emphasizing their scalability from 3 L to 2000 L for mammalian cell culture and recombinant protein production, and outlines critical engineering parameters for successful scale-up in biomanufacturing processes.
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