September 21, 2023

A Look into Biologic Scale-Up Strategies

Optimizing cell-culture processes for monoclonal antibody (mAb) production is a key factor in scaling up manufacturing to commercial levels. To maximize cell-culture output, strategy is required that takes into consideration factors such as cell culture media, environmental monitoring, and process controls. Yet, despite decades of process optimization, there remain stubborn challenges—or new challenges that have arisen–during the scale up of cell culture processes.

Read more

Tags: Biosimilars, biologic development, biologic manufacturing, process development, biologic scale-up