Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers

By Dr. Kirk Beebe, Director of Application Science, Metabolon, Inc.

Biologics are an integral part of the landscape of current therapies as pipelines continue to fill with them. Due to their importance and this ever expanding pipeline, the 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 assertion is derived from the knowledge 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 (bioreactor), nutrition (media) and genotype (Fig. 1) and the closing-in of the demands described above. Thus, having a means to unravel this network will be paramount in addressing these challenges. Fortuitously, metabolomics is a new paradigm for bioprocess optimization that leverages modern technology and innovation with biological knowledge that is rooted deeply in the past.