Development and Qualification of a Scale-Down Mammalian Cell Culture Model and Application in Design Space Development by Definitive Screening Design



In this study, a scale-down model representing commercial-scale cell culture process of adalimumab biosimilar HS016 was first developed based on constant power per volume principle and then qualified by multivariate data analysis and equivalence test method. The trajectories of the bench-scale process lie in the middle of the control range of large-scale process, built by multivariate evolution model based on nutrients, metabolites, and process performance datasets. This indicates that the small-scale process performance is comparable with that of the full-scale process. Learn More