Implementation of QbD strategies in the inoculum expansion of a mAb production process.

ABSTRACT: The quality by design approach was introduced to the biopharmaceutical industry over 15 years ago. This principle is widely implemented in the characterization of monoclonal antibody production processes. Anyway, the early process phase, namely the inoculum expansion, was not yet investigated and characterized for most processes. In order to increase the understanding of early process parameter interactions and their influence on the later production process, a risk assessment followed by a design of experiments approach was conducted. The DoE included the critical parameters methotrexate (MTX) concentration, initial passage viable cell density and passage duration. Multivariate data analysis led to mathematical regression models and the establishment of a designated design space for the s

SUBMITTER: Bohl OJ 

PROVIDER: S-EPMC7923587 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature