Author Archives:Christoph Herwig

Developing Process Control Strategies for Continuous Bioprocesses

流程控制使生物制造商能够确保操作参数在定义的规格范围内。应在过程开发的早期阶段建立控制策略,同时使用基于风险的方法(例如设计(QBD))和工艺分析技术(PATS)来定义过程和产品性能。确认流程控制为产品开发的重要组成部分,创造了更多的过程知识和理解,并为过程优化提供了第一步。通过了解过程性能与产品质量的关系,…

Data Science, Modeling, and Advanced PAT Tools Enable Continuous Culture

Bioprocesses traditionally use (fed-)batch cell culture processes for production of recombinant proteins and therapeutics. In batch bioprocessing, material flow is discrete, with a hold step between two unit operations, and product is harvested only once for each unit operation. Batch processes have been studied extensively and optimized through numerous advancements in experimental design (1, 2), monitoring (3–5), measurement techniques (6–9), and control strategies (10–12). However, such processes require large facility footprints for equipment (13) as well as sterilization, load, and…

CHO细胞文化的在线监视

Mammalian cell culture processes are very important in the production of recombinant proteins such as vaccines, antibodies, and pharmaceuticals for clinical applications. The physiology of mammalian cells is highly sensitive, leading to the need for sophisticated process technologies. A reliable sensor set-up is required to control major process parameters such as pH, dissolved oxygen, carbon dioxide, cell density, and feed rates. If such set points are not controlled tightly, then product quality and quantity might be altered. In addition, a…