Effects of process intensification on homogeneity of an IgG1:κ monoclonal antibody during perfusion culture.

ABSTRACT: The pharmaceutical industry employs various strategies to improve cell productivity. These strategies include process intensification, culture media improvement, clonal selection, media supplementation and genetic engineering of cells. However, improved cell productivity has inherent risk of impacting product quality attributes (PQA). PQAs may affect the products' efficacy via stability, bioavailability, or in vivo bioactivity. Variations in manufacturing process may introduce heterogeneity in the products by altering the type and extent of N-glycosylation, which is a PQA of therapeutic proteins. We investigated the effect of different cell densities representing increasing process intensification in a perfusion cell culture on the production of an IgG1-κ monoclonal antibody from a CHO-K1

SUBMITTER: Liang G 

PROVIDER: S-EPMC10965650 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature