TEA is critical for making strategic decisions throughout the entire process, from process conception to scale-up and commercialization. Arete can create a TEA tailored to your process to identify metrics necessary for economic success at scale and understanding vulnerabilities to process economics (e.g. raw material costs) that are critical for successful commercialization. For instance, what are the economics and profit margins of producing at a CMO versus building, owning, and operating a facility?
Arete will work with you to optimize fermentation processes and media formulations to not only maximize titer, rate, and yield, but to also make sure the process is ready for scale-up and aligned with purification
Tech transfer can be taken for granted, and a small detail can be the difference between reproducing results and people on both sides asking "What went wrong?" Attention to detail and collaboration are critical to replicating results at a second facility, whether for just fermentation or a whole production process, and Arete has the expertise to facilitate your tech transfer.
Scaling up a fermentation process can be for demonstration purposes, to generate material, or to generate design data for a production facility. Knowing what you need out of scale-up is important, and Arete will deliver your scale-up goals. This includes making sure your process is ready, work with you to prepare a process description, and manage tech transfer and scale-up, whether to pilot scale (50 – 5000L) or commercial scale (10,000L and greater).
Each fermentation facility has unique capabilities and it is critical to match a customer’s needs to what a facility can provide. This is true for CROs (contract research organizations), CMOs (contract manufacturing organizations), or even retrofits of existing production facilities. Arete can evaluate the process, the facility, and provide recommendations based on criteria such as fit, expertise, and costs.
Arete can produce projections for capital equipment costs (CAPEX) and operating costs (OPEX, or COGs) based on process mass and energy balances (upstream and downstream). These can be used to generate a preliminary engineering design package, such as identifying unit operations, creating process flow diagrams, and even specifying design and build requirements for fermentation equipment.
Arete BioProcess Consulting LLC is a Limited Liability Company in Colorado