Improved Titer in Late-Stage Mammalian Cell Culture Manufacturing by Re-Cloning.

ABSTRACT: Improving productivity to reduce the cost of biologics manufacturing and ensure that therapeutics can reach more patients remains a major challenge faced by the biopharmaceutical industry. Chinese hamster ovary (CHO) cell lines are commonly prepared for biomanufacturing by single cell cloning post-transfection and recovery, followed by lead clone screening, generation of a research cell bank (RCB), cell culture process development, and manufacturing of a master cell bank (MCB) to be used in early phase clinical manufacturing. In this study, it was found that an additional round of cloning and clone selection from an established monoclonal RCB or MCB (i.e., re-cloning) significantly improved titer for multiple late phase monoclonal antibody upstream processes. Quality attributes remained co

SUBMITTER: He Q 

PROVIDER: S-EPMC9030702 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature