Investigation of the interactions of critical scale-up parameters (pH, pO₂ and pCO₂) on CHO batch performance and critical quality attributes.

ABSTRACT: Understanding process parameter interactions and their effects on mammalian cell cultivations is an essential requirement for robust process scale-up. Furthermore, knowledge of the relationship between the process parameters and the product critical quality attributes (CQAs) is necessary to satisfy quality by design guidelines. So far, mainly the effect of single parameters on CQAs was investigated. Here, we present a comprehensive study to investigate the interactions of scale-up relevant parameters as pH, pO₂ and pCO₂ on CHO cell physiology, process performance and CQAs, which was based on design of experiments and extended product quality analytics. The study used a novel control strategy in which process parameters were decoupled from each other, and thus allowed

SUBMITTER: Brunner M 

PROVIDER: S-EPMC5274649 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature