A new strategy in bioreactor scale-up and process transfer using a dynamic initial vvm according to different aeration pore size.

ABSTRACT: Monoclonal antibody drugs have grown into a drug category with a market size of over $100 billion since the first product was launched on the market, which naturally creates a large demand for production. At the same time, the $100 billion market is distributed among more than 200 listed drugs, which indicates that the production demand for monoclonal antibody drugs is diverse. To meet this demand, major suppliers offer single-use bioreactors of all sizes. These single-use bioreactors with different specifications, especially the inconsistency of aeration pore sizes, pose great challenges for technology transfer and scale-up production, and the conventional scale-up strategies of constant Power input/volume ratio (P/V) and constant vessel volume per minute (vvm) can no longer meet the need

SUBMITTER: Ding H 

PROVIDER: S-EPMC11420042 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature