Employing metabolomics in cell culture and bioprocessing to gain greater predictability, control and quality

Biologics are an integral part of the landscape of current therapies as pipelines continue to fill with them. Demands continue to escalate due to cost pressure, competition, regulatory requirements, disposable systems, and biosimilars. To date, these demands arguably have primarily been met with empirical understanding. However, there is a critical need for new approaches, tools, and technologies to deliver deeper understanding beyond the empirical realm. This sense comes from an emerging realization that the factors contributing to a predictable optimized process that yields high quality product every time are not simply conferred by a single gene or variable, but instead, a complex network of environment and genotype. Thus, having a means to unravel this network will be paramount in addressing these challenges. The maturity of the field of metabolism and its proximity to the phenotypic output of the cell provides this opportunity for beginning the process of deepening our understanding of these complex systems. Metabolomics is a modern approach for extensively surveying the metabolism of a particular system. Illustrating this will be examples of how metabolomics was used to “diagnose” the mechanistic underpinnings of cell culture systems to reveal routes for improvement in yield and quality.