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不断增长，开发中的哺乳动物细胞产品数量不断增加，以及有必要使大流行病疫苗的生产现代化并加快生产速度，这些都推动了对开发高效、具有成本效益和稳健的细胞培养方法的需求。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，代谢和生产力的众多参数，目前仅部分了解培养中哺乳动物细胞的复杂行为。反过来，这种知识的缺乏阻碍了有效控制战略的制定，而有效控制战略对于降低生产成本、确保高产和保持产品质量至关重要。因此，这一领域的进步是必要的，对于缩短上市时间和增加新的和急需的治疗剂向临床和市场的供应至关重要。

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.