Consistent development of bioprocesses from microliter cultures to the industrial scale

TLDR

Bioprocess development is currently slow and costly compared to chemical processes. The paper reviews bioprocess development phases from a business perspective and argues that a paradigm shift is needed by applying engineering strategies early in product development. The authors review available systems and technologies, and propose using statistical design of experiments, fed‑batch, minibioreactors, online sensors, process modeling, control tools, and automation to improve success rates and identify optimal parameters. These strategies directly benefit early biomolecular screening and initial small‑scale production of the target molecule.

Abstract

Bioprocess development today is slow and expensive compared to chemical process development. A drastic paradigm shift is necessary and possible by the consistent application of engineering strategies that are typically used in the process development phase already in the early product development. Aside from providing a consistent pathway, strategies such as statistical‐based design of experiments, fed‐batch, minibioreactors, new on‐line sensors, process modeling, and control tools in combination with automation of manual steps offer a higher success rate and the opportunity to find the optimum parameters and operation point. This also directly benefits the early phases of biomolecular screening and initial production of small amounts of the target molecule. The paper reviews the bioprocess developmental phases from a business perspective and the available systems and technologies.