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:
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
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:
Development begins by selecting single-cell clones that can produce the biologic of interest, then screening for clones that are stable, productive, and scalable
Achieving consistent cell culture performance requires careful screening, selection, and optimization of media formulations and feed
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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