Host Cell Proteins in Biologics Manufacturing: The Good, the Bad, and the Ugly.

ABSTRACT: Significant progress in the manufacturing of biopharmaceuticals has been made by increasing the overall titers in the USP (upstream processing) titers without raising the cost of the USP. In addition, the development of platform processes led to a higher process robustness. Despite or even due to those achievements, novel challenges are in sight. The higher upstream titers created more complex impurity profiles, both in mass and composition, demanding higher separation capacities and selectivity in downstream processing (DSP). This creates a major shift of costs from USP to DSP. In order to solve this issue, USP and DSP integration approaches can be developed and used for overall process optimization. This study focuses on the characterization and classification of host cell proteins (HCPs

SUBMITTER: Kornecki M 

PROVIDER: S-EPMC6698861 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature