Every new process innovation goes through two phases: 1) make the process work; and 2) now make it work better.
For single-use biopharma processing, the “make it work” phase occurred in the 1990s, 2000s, and early 2010s. Since then, single-use processing has been proven effective so the market has moved into the “make it better” stage. This entails faster, more efficient processing with higher output at a lower cost. One way the upstream process can achieve these goals is through continuous manufacturing techniques. In fact, a BioPlan Associates survey released in 2024 indicates that 72% of the 345 respondents expect perfusion, an upstream continuous process, to be fully adopted by most facilities in the coming years.
Constantly filtering upstream biologics via perfusion or another means increases the cell density prior to and during the clarification and harvest steps. This approach results in less down time from scale-up batch processing and less consumable waste than traditional batch-fed processes where cells are transferred through more steps, therefore using additional holding bags and other disposable containers.
While continuous manufacturing practices has been shown to work in the lab, several factors can affect its success at commercial scales. The industry is looking to single-use system suppliers to help address the requirements of continuous bioprocessing.
A key issue in large bioreactors is the efficient transfer of large volumes of fluids with minimal flow path disruption to the perfusion filters. Newer sterile connectors, for example, have increased the internal diameter (ID) of the couplers to 1.5”, allowing maximum flow while handling the elevated side-load and tensile forces seen at large flow paths. Makers of other system components—tubing, fittings, pinch clamps, etc.—have also introduced 1.5” ID options that can be incorporated into systems that effectively bridge the gap between the tanks and the filter.
Also, because a key goal of continuous manufacturing is efficiency, it’s easy to see the value of relying on the same type of components that were used in smaller flow paths when possible. Components that function the same way and use the same materials streamlines validation and simplifies scale up and tech transfer.
For example, the largest connector in CPC’s AseptiQuik® family, the 1.5” AseptiQuik W connector, is made of same flow path materials—polycarbonate and platinum-cured silicone—as CPC’s other sterile connectors, easing adoption into continuous manufacturing environments. The larger connector also functions the same way as other smaller connectors in the line, making it simple for technicians to incorporate and use in new processes.
Nearly 80 percent of the experts (79%) surveyed by BioPlan Associates expect to see commercial-scale continuous manufacturing facilities within five years. As continuous manufacturing matures, more innovation is required to “make it (even) better.” New solutions are helping make continuous processing a reality by transferring fluids faster, more efficiently, and at a lower cost.
To learn more about efficient fluid management and sterile processing in continuous manufacturing, talk to the experts at CPC or visit: AseptiQuik® W Large-volume Connector Series.
Source: 20th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production. BioPlan Associates. Spring 2023.