Knowing your products and therapies have life-saving potential helps keep you motivated, , but logistics and supply chain management can keep you up at night. And few aspects of single-use bioprocessing are as logistically complex as fluid management. At Cytiva, we’ve worked with hundreds of CDMOs and biomanufacturers to make their fluid management systems more efficient and resilient to future challenges. Not only has this work helped our customers — it’s also given us crucial insight into what really matters when it comes to designing a robust and resilient process. Here, our team shares five top considerations for futureproofing your bioprocessing fluid management system.
1. Standardization is the key to reducing logistical complexity. ”Fluid management is one of the more complex aspects of bioprocessing,” says Erik Storm, fluid management platform leader at Cytiva. ”That’s because of the large number of parts you need on hand to run a single-use facility, and because of the customization of those parts.”
Custom-made components such as connectors and jumpers are used throughout single-use fluid management systems, but they come with risks: they’re often built to order, so they are less likely to be in stock when you need them. They may not be supplied with the data you need for qualification. And often, the more distinct parts a fluid management assembly uses, the more complicated inventory tracking and record keeping becomes.
Frequently, standard parts can be used just as effectively, if not more efficiently, to build bioprocessing fluid management systems. Standard parts are produced regularly rather than made to order, so they’re more likely to be in stock when you need them.
Standardization also simplifies inventory. Having fewer part numbers to track “makes for easier handling of the single-use assembly,” says Chris McCoy, single-use technology leader at Cytiva. “If you're using a part that's in several of your process steps, it's a lot easier than if you're using a different part for each one of those steps.”
Storm adds that even though every product and process is different, the system components don’t have to be. You can use standard parts to configure a fluid management system that fits your needs. And switching to as many standard components as possible has turned out to be one of the best ways to help customers reduce manufacturing complexity and minimize downtime.
2. The best time to standardize is now. Whether you’re building a new facility or implementing a new unit operation, standardizing your bioprocessing fluid management system can save significant costs. Designing in standard components will maximize savings and benefits — but if that’s not feasible, you can still benefit from converting a highly customized process to a standardized configuration. Adding an inline dilution or perfusion step? Consider using standard parts or assemblies for that step .
3. Know where your products are coming from. As biotech manufacturers move toward end-to-end single-use processes, close communication between suppliers and customers becomes more important as a way to manage logistics. One of the best ways to get closer to suppliers? Get closer to them, literally, by using suppliers who manufacture products regionally. Why? Having a single global site for manufacturing means that local shifts in availability or transport logistics can have ripple effects throughout the world. Having only one global facility can also pose regulatory and cost challenges related to navigating differences in price or availability of labor and in regulations of various regions.
”In-region for-region” manufacturing, in which distributed manufacturing facilities serve customers in each region, simplifies some of these challenges and affords greater first-hand knowledge and communication with suppliers. ”Over the past few years,” Storm says, ”Cytiva has been standing up in-region for-region manufacturing to bring us closer to customers.” Sites in the United States, China, and the United Kingdom serve North America, China, and Europe, helping simplify the logistics of getting the equipment you need.
4. Documentation is key. No matter where you source your single-use bioprocessing fluid management components, make sure your vendor provides a robust documentation package. Documentation and data such as leachables and extractables are necessary for qualification of the parts used in single-use bioprocessing. Having a complete bill of materials for your single-use fluid management systems or assemblies helps you guard against supply chain issues and manage inventory, and it support qualification . Other important documentation includes global chain of custody records to provide traceability, and validation guides.
5. Take advantage of supplier expertise. Implementing single-use technology for bioprocessing is complex even with standard parts — especially if you’re modifying an existing facility rather than building a new one. We’ve spent years helping large biopharma manufacturers develop and optimize single-use solutions — and now we’re bringing our expertise to bear at the unit operations scale. Stacey Willard, head of technical programs at Cytiva, explains: "Incorporating standard products into an existing process can be more complicated, but we can offer our extensive expertise in this area to assist you in determining what can be standardized within your process.” Chris McCoy agrees: ”We talk to customers on their level, so we can help address technical problems and find the best path forward.”
Interested in building a better fluid management system? Learn more and get in touch here.