Mikio Inoue

Development of Large-Scale Suspension Reactor for Anchorage-Dependent and Independent Mammalian Cell Culture

Mammalian cell culture is being used with greater frequency every day for commercial production of pharmaceutical products. These production activities must be reproducible and provide homogeneous products in order to assure that the strict quality control necessary for process validation is achieved. Batched GMP operations in stirred tank reactors have been traditional means by which the necessary process reproducibility and product homogeneity have been achieved for validation. At the commercial scale where kilogram quantities of protein per year are required, batch suspension tank reactor production methods have been found to be the most suitable. Because commercial mammalian cell culture production may necessitate the use of anchorage-dependent cells as well as anchorage-independent ones, any system for studying this process must be capable of culture cells by both means effectively at large scale. To collect the engineering data for industrial scale pharmaceutical plant design analysis production run testing, we developed and currently operate a pilot scale mammalian cell culture system which cultivates anchorage-dependent and -independent cells at our facilities.