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

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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.