Developing biological products is a complex process that requires multiple steps to launch an effective product. Biological products are defined as products containing living microorganisms, such as probiotics or microbial inoculants used in agriculture. These steps include strain discovery to identify active ingredients for a target application, early research and development (R&D) to show efficacy and prove the mode of action for the active ingredient in the intended application, fermentation and formulation processes to scale properly from the laboratory to 10,000s of liters, shelf stability of the active ingredient and formulated product, an acceptable cost of goods from manufacturing to consumer, and application methods that preserve the active ingredient’s functional properties. In recent years, there have been significant advancements in strain discovery and engineering, driven by synthetic biology, to identify new genes or to produce molecules with desirable modes of action at the bench scale. Government funding and private funding have been more abundant for early-stage research. More recently, fermentation and its scale-up, referred to as biomanufacturing, are gaining more attention, and strategic investment in the last few years signals that innovation and capacity of the industry are moving in the right direction, although slowly. Bioformulation, which refers to the technologies, processes, and ingredients to keep the biological product stable from the time of manufacturing to the time of use, is critical for creating biological products. Research into formulation and application methods has been limited and often occurs through proprietary efforts within companies. Best practices in formulation, storage, and applications are still oriented toward synthetic chemical products. Keeping practices designed for chemistry and forcing biology to fit that practice can negatively impact biological product use and performance. This article seeks to lay out a roadmap for biological product development, highlighting the critical aspects of different stages and the associated knowledge and funding gaps that need to be considered.
Fife et al. (Wed,) studied this question.