Currently, biopharmaceutical companies are striving to produce biologics more efficiently, with a lower cost point and fewer people. Most small-scale media and buffer operations are carried out with small bottles of liquid media, but as processes are scaled up to manufacturing levels, that is no longer a viable option. Costs of shipping liquid are simply prohibitive, so the industry has migrated to using media and buffer in a powder form. In fact, 90% of cell culture media and buffer for sale is now in a powder form that needs to be hydrated, mixed and packaged to be used in the process. This “just in time” hydration allows for increased compliance and process efficiency.
One of the biggest concerns with this process is that it could become an entryway for contaminants to enter the process. Everyone remembers the story of a high-profile biologics company that had a facilitywide animal virus contamination, and how it resulted in shortages of vital medicines and a long shutdown to determine the root cause. To reduce the chances of such contamination, the entire system must be closed.
Making biologics safely also means designing the process to reduce contamination risk at every step, even those that may not seem obvious. One of those often overlooked steps is mixing media and buffer powder during the process. It is still common to see people pouring open buckets of powdered media into a mixing tank, with powder flying into the air and around the room. This leads to a dirty environment that is hard to clean and validate. We have found a way to make this process seamless, easy and safe, using a system that is the state-of-the-art solution in single-use facilities.