Optimized cell-culture media is essential to enhance production of a quality biopharmaceutical product. In the past decade, the biopharmaceutical industry has witnessed previously unimaginable productivity gains that can largely be attributed to improvements in cell-culture media.
Historically, media contained animal-derived serum to maintain optimal mammalian cell growth and productivity. The recent introduction of regulations requiring the removal of serum and other animal-derived components in all biomanufacturing process has led to the introduction of leaner, more defined animal-component-free media (ACF). This shift in media design is now almost complete. However, the biopharmaceutical industry is always looking for improvements to reduce process timelines and time to market. Where once process development scientists strived for the one-media-fits-all approach, a new paradigm is now emerging with media being optimized for a particular cell line, clone, or process.
The primary challenge for the biopharmaceutical industry today is streamlining of the entire production process to deliver efficient and robust processes that are predictable and deliver a consistent product. Media developers are now focusing on individual processes and product requirements with the development of platform media containing optimized feeds and supplements to meet their specific process needs. A holistic approach to process development is becoming more common, with the understanding that a quality optimized upstream process translates downstream to a quality final product.This article examines different media-development strategies that allow process-development scientists and biologic manufacturers to optimize their upstream process through the use of specifically designed supplements and feeds. Specifically, the article describes how plant-based hydrolysates are a proven and effective alternative to serum- or animal-derived media supplements, how complex and chemically defined hydrolysates can enhance process performance in a cell-line specific way, as well as describing the development of more defined and consistent hydrolysate products that further acknowledge the process-specific trends in media development.