A physiological state-based approach to the development and control of mammalian cell culture processes

对大量生物药物的需求日益增长，正在开发的哺乳动物细胞产品的数量越来越多，以及需要现代化和加快生产应对大流行的疫苗，这些都推动了开发高效、成本效益高和强大的细胞培养过程的需要。尽管哺乳动物细胞技术取得了进展，但仍然存在重大挑战；由于控制细胞生长、新陈代谢和生产力的众多参数，目前对哺乳动物细胞在培养中的复杂行为只有部分了解。反过来，这种知识的缺乏阻碍了有效控制战略的制定，这些战略对于降低生产成本、确保高产量和保持产品质量至关重要。因此，这一领域的进展对于缩短上市时间和增加临床和市场急需的新的治疗剂的供应是必要的，也是至关重要的。

The growing demand for large amounts of biopharmaceuticals, the increasing number of mammalian cell products in development and the necessity to modernize and speed up the production of vaccines for pandemic readiness are driving the need to develop efficient, cost-effective and robust cell culture processes. Despite progress in mammalian cell technologies, significant challenges still remain; the complex behaviour of mammalian cells in culture is currently only partially understood because of the multitude of parameters governing cell growth, metabolism and productivity. In turn, this lack of knowledge has hindered the development of effective control strategies, which are vital for reducing production costs, ensuring high yields and maintaining product quality. Advancements in this area are thus needed and crucial to reduce the time-to-market and increase the supply of new and much needed therapeutic agents to the clinic and market.