Scaling Up mAb Production with a Platform Medium and Feed System

As the monoclonal-antibody (mAb) market continues to grow, it is becoming increasingly important for pharmaceutical and biotech companies to accelerate process development and establish a scalable manufacturing process capable of achieving high titers and consistent product quality. Central to this is a cell culture media and feed system that can provide the required nutrients for optimal cell growth, viability, and function, as well as facilitate a seamless transition from development to clinical and commercial manufacturing.

However, choosing an appropriate system can be a complex and time-consuming process, often requiring the evaluation of multiple medium and feed options. Platform systems, consisting of a medium and complementary feed developed for a specific cell line and application, have emerged as a valuable option for developers to help simplify selection and increase scale-up efficiency.

To meet the need for high-performance platform mAb manufacturing solutions, Thermo Fisher Scientific has developed the Gibco™ Efficient-Pro™ Medium and Feeds System. The Efficient-Pro System consists of a basal CHO cell medium with two single-part feeds formulated for use with CHO-K1 and CHO-S/DG44 cell lines, respectively.

In this article, we demonstrate the ability of the Efficient-Pro system to maintain mAb titers and quality from development to pilot scales, highlighting its suitability for use as a scalable platform solution to support fed-batch mAb production. We also discuss the additional design features of the Efficient-Pro system, intended to help manufacturers maximize process efficiency and implement a reliable commercial workflow.

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