Industrial biotechnology leverages fermentation processes to produce an array of valuable products, including biofuels, biobased chemicals, specialty chemicals, nutraceuticals (e.g., cannabidiol), and the ingredients required for the burgeoning market of meat, dairy, and seafood substitutes. Once a company has successfully developed and optimized its bioprocess, encompassing fermentation and purification, at the laboratory scale, it is imperative to embark on a comprehensive preparatory phase before transitioning to the scale-up phase within the realm of industrial biotechnology. This preparatory phase entails meticulous budgeting to support piloting or demonstration activities, coupled with the precise delineation of scale-up objectives.
Several compelling motivations drive the imperative to scale up a bioprocess, each profoundly influencing the duration, cost, and execution of scale-up endeavors. One primary rationale for scaling up is to validate the functionality of the process at a relevant scale, typically around 100 times the volume employed in laboratory settings, which equates to fermenters ranging from 500 to 2000 liters. In this context, the paramount aim is to establish that the process can faithfully replicate its performance at a larger scale, striving for near-identical metrics as observed in small-scale trials. Such campaigns are often brief, requiring as few as three reproducible runs, and may omit downstream processing if the primary focus is fermentation scale-up. The outcomes of such demonstration campaigns frequently serve to meet investor requirements or generate interest through press releases.
A secondary rationale for scale-up is the piloting of the process to amass data indispensable for the design of a full-scale fermentation production facility. This endeavor differs significantly from the first scenario, as the pivotal output is the generation of design data itself. The pilot facility must closely mirror the intended production process, incorporating all relevant equipment and accounting for possible impurity buildup through recycling streams. The duration of such campaigns typically extends from several months to potentially up to a year. Extensive time investment at the pilot scale yields more robust design data and facilitates the smoother commencement of production facility operations.
The third imperative for scale-up pertains to the generation of substantial product volumes, either through a Contract Manufacturing Organization (CMO) or at a pilot facility. Often, the produced material is used as a market seeding strategy to stimulate interest in biobased products. In this context, the primary goal is to generate products that adheres to specifications, assuming that the process has undergone optimization not only in the laboratory but also at the pilot scale. Prioritizing product output over operational efficiency, the piloting or CMO facility may employ equipment that is not the optimal match for the process but ensures quality product delivery within a reasonable timeframe and cost, even though profitability may not yet be achieved, contingent on the product’s market value. It is imperative for a company embarking on industrial biotechnology scale-up activities to be financially prepared, as the burn rate increases substantially once piloting or production commences.
Effectively conducting a scale-up campaign necessitates the involvement of experts in the fields of fermentation and purification, equipped with substantial experience in large-scale operations. These experts are typically engineers or scientists who have operated pilot-scale equipment and managed pilot or production campaigns. Their responsibilities encompass evaluating facilities to assess their suitability for accommodating the process, identifying the need for renting or procuring additional equipment, and evaluating the proficiency of the personnel operating the facility. Furthermore, these experts must possess the capacity to formulate budgets, oversee logistics such as procurement and delivery of feedstock and product, manage client-CMO relationships, and ensure that efforts remain aligned with scale-up objectives. Hence, individuals responsible for the industrial biotechnology scale-up of an industrial fermentation process must possess a fusion of adept project management skills and the essential technical acumen.
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