Upstream and Downstream Processes – A Holistic View

This article was originally published in the eBook “ Future proofing Bioprocessing from Upstream to Downstream”. You can download all the articles in the series, by downloading the eBook. Not everyone has the luxury of building from the ground up. How do you create a unified system between upstream and downstream with existing equipment and processes? And if you have the ability to build from the ground up, how can you ensure that your design is future proof? We spoke with Phil Sanders, Biotech Chief Innovation Officer from Agilitech, to develop a set of best practices for creating a holistic process from upstream to downstream. Create a Growth Plan with Scalability Built in When companies are developing their process, it is easy to have a more myopic view of focusing on what is needed right now. Unfortunately, from a planning perspective this is very difficult because what is needed now often doesn’t work as companies need to scale up. When Agilitech works with customers, they ask customers to help them envision what their needs will be 3 years from now, 5 years from now, and at full commercialization. These answers are critical for decisions that companies will make right now. Because speed and cost are two driving factors, especially at the beginning of operation, companies often look for what is available now and what is the most cost-effective option. However, later they may learn that the process that they have created can’t scale up or can’t meet other process or quality related requirements. At that point, companies frequently wish they would have made different decisions earlier that took future needs into consideration. One thing that Agilitech is helping customers with is bringing a holistic view. For instance, even if the project is related to upstream, it is important to think about what is the downstream going to look like. What will it look like in a process development environment, how about a manufacturing environment? Thinking about the scalability earlier in the process allows room to build scalability into the design for the future. It is common in an industry that is always pushing for speed and efficiency to think about what must be produced now, but later customers often realize that they have wasted a tremendous amount of time creating a process and buying equipment that will ultimately need to be replaced for something that is more scalable or flexible; therefore, off-the-shelf is not always the best solution, even if it serves the purpose in the moment. Don’t Get Locked into a Proprietary Solution – Remain Brand Agnostic Agilitech Single-use Multipurpose Filtration Systems are Redefining FlexibilityThe benchtop option (up to 3 LPM) and larger system (up to 90 LPM) both adapt to virtually any external filtration system They can be used for multiple applications including sterile filtration, depth filtration, or virus filtration. Fit-forpurpose options permit reconfiguring the flow path to add more inlets, outlets, and more.     It can be tempting to lock into a single brand or a proprietary solution for your process needs from a convenience or discount standpoint. However, there are several reasons why you may want to remain brand agnostic. Locking into a single solution may limit the process in the future. Often locking into a platform that works now results in limits on equipment size and volume that require redesigns that are costly and time consuming. A brand-agnostic approach allows companies to create a process that is flexible where all equipment works well together and communicates well across the entire process. Proprietary software can be extremely limiting in scalability and working with other systems, particularly between upstream and downstream. Companies can find themselves in a situation where they must add another control system to expand their process for a more scalable solution. Proprietary solutions can also impact support and whether updates and ...