Choosing Between Single-Use and Stainless Steel Technology for Biomanufacturing

Biopharmaceutical manufacturers are currently facing the challenge of meeting a surge in demand for essential therapeutics while simultaneously striving to achieve sustainability targets. The evolving industry has sparked a debate between single-use bioreactors (SUBs) and stainless steel bioproduction, each presenting its own set of advantages and disadvantages. As manufacturers endeavor to identify the most suitable technology for their biomanufacturing requirements, the decision between single-use and stainless steel systems depends on factors such as molecule type, demand phase, patient population, and facility type.

Single-use technologies (SUTs) have emerged as a proficient and adaptable alternative to stainless steel bioreactors (SSBs), offering benefits such as reduced downtime, faster turnaround, and easier assembly and disassembly of disposable elements. The scalability of SUBs also equips manufacturers with the ability to swiftly scale up or down, rendering it a practical choice for companies with a focus on research and development.

In terms of sustainability, SUBs have exhibited substantial reductions in water consumption and facility energy use in comparison to SSBs. Nevertheless, concerns persist regarding waste generation and environmental impacts associated with the disposal of single-use components. Lifecycle assessments have underscored the significance of recycling and reusing single-use components to mitigate the adverse environmental repercussions of this technology.

Moreover, SUBs have demonstrated a 37% decrease in consumable costs when compared to stainless steel, ensuring considerable benefits in water savings and cost effectiveness. While SSBs boast well-established durability and higher initial costs, operating expenditures can rise due to amplified water usage and labor costs.

SUTs also provide enhanced flexibility and scalability for manufacturers, permitting shorter setup times, reduced cleaning requirements, and easier customization of reactor size and configuration. This renders it an appealing option for companies producing a variety of products in different volumes and seeking to enhance production efficiency.

Both SUTs and SSBs offer the possibility of implementing quality process controls, each presenting unique advantages in terms of documentation processes and change control. Manufacturers must weigh the economic and environmental consequences of their choice, navigating between lower upfront capital expenditure with SUTs but amplified operating expenditures due to consumable costs, and higher initial costs with SSBs but potential long-term savings.

As the biopharmaceutical industry continues to advance, SUTs are making significant progress towards matching the capabilities of stainless steel systems. With an increasing emphasis on sustainability, flexibility, and performance, SUTs are evolving into an attractive option for biomanufacturers seeking to enhance efficiencies, increase yield, and achieve their environmental, social, and governance (ESG) objectives.

In conclusion, the choice between single-use and stainless steel technology for biomanufacturing ultimately hinges on a biomanufacturer’s unique requirements and considerations. While SSBs remain a viable option for large-scale manufacturers, SUTs are positioned to deliver increased flexibility and sustainability, rendering them an appealing option for companies aiming to streamline their production processes.

About the author:
John P. Puglia, Ph.D., is the senior director of research and development at Thermo Fisher Scientific’s bioprocessing business, with a focus on single-use technologies. His expertise in polymer science, sustainable engineering, and high-purity manufacturing has contributed to the advancements in single-use bioreactors and their role in biopharmaceutical manufacturing.