It Depends: The Real Answer To The Single-Use Or Stainless-Steel Question

During the past decade there have been innumerable comparisons between stainless steel and single-use (SU) biomanufacturing systems. Issues such as capacity, scale-up, and flexibility dominate these discussions, and for good reason, considering each has a specific effect on the cost a sponsor will incur. Other topics evaluated as part of this comparison include energy usage, cleaning validation, cross-contamination risks, and the disposal of plastic waste.

But anyone who has delved even slightly deep into this topic knows there isn’t a simple, clear cut answer to which system is “best.” Yes, over the years there have been improvements to SU technologies (e.g., level of extractables and leachables), and the increase in cell culture titers and advances in cell line expression have furthered the use of single-use bioreactors even for some commercial production. Stainless steel systems, though, are still being built and will play a pivotal role in the production of new biologics that will require huge volumes for larger patient populations (e.g., Cancer, Alzheimer’s, diabetes). The reality is that stainless steel and SU can and will coexist – and often do in today’s hybrid bioprocessing manufacturing environments.