Industrial biotech uses fermentation processes to make biofuels, biobased chemicals, specialty chemicals, nutraceuticals (e.g. cannabidiol), and even ingredients for the recent rise of meat, dairy, and seafood substitutes. Once a company has a bioprocess (including fermentation and purification) fully tested and optimized at lab scale, then the company needs to prepare itself before industrial biotech scale up activities begin. This includes proper budgeting to support piloting or demonstration activities along with clearly defining the goals of scale-up.
There are several reasons to scale-up a process, and each will drive the length, cost, and execution of scale-up activities. One reason to scale-up is to demonstrate the process works at a relevant scale, usually about 100x of that used in the lab, or in the range of 500 – 2000L fermenters. Here the goal is to prove the process reproduces at larger scale, i.e. nearly identical metrics are achieved as seen at small scale. This is usually a short campaign, can be completed with as little as three reproducible runs, and may not include downstream processing if the primary concern is fermentation scale-up. The results of such a demonstration campaign are often used to meet investor requirements and/or create interest through press releases, for example. A second reason to scale-up is to pilot the process in order to generate data to design a fermentation production facility. This is significantly different from the first reason as design data is the product. The pilot facility must be a good match to the production process (i.e. has all relevant equipment), piloting must include any recycle streams to properly account for possible buildup of impurities, and the campaign will likely be longer, anywhere from several months to up to a year. The more time spent at pilot scale, the better the design data, and the smoother start-up of a production facility. The third reason to scale-up is to generate large quantities of product, either through a CMO (contract manufacturing organization) or at a pilot facility, and the material is usually used to seed the market and generate interest in the biobased product. Here the goal is to generate in-spec product and assumes the process has not only been optimized in the lab but also at pilot scale. As the priority here is to make product, the piloting or CMO facility may not have equipment that is the best match or runs the process efficiently (e.g. lower yield or recovery), but produces quality product in a reasonable time and for a reasonable cost (although it could still be at a loss, depending on the value of the product). Finally, when a company moves into industrial biotech scale up mode, it needs to be financially ready as the burn rate will increase significantly once any piloting or production begins.
In order to conduct a successful scale-up campaign, the company needs experts in fermentation and purification with large scale experience in addition to having clearly defined goals as mentioned above. These experts are usually engineers or scientists that have operated pilot equipment and managed pilot or production campaigns. They can evaluate facilities to determine how well it matches the process, if additional equipment will need to be rented or purchased and gauge the level of expertise of those operating the facility. Further, the experts will need to be able to prepare budgets, manage logistics (such as purchasing and delivery of feedstock and product), manage the relationship between client and CMO and keep efforts on task to achieve scale-up goals. Therefore, good project management skills along with the prerequisite technical skills are required of those in charge of industrial biotech scale up of an industrial fermentation process.
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