Single Use or Stainless Steel?
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing.
As the biopharmaceutical market continues to expand and reliance of SU manufacturing rises, demand for SU consumables (i.e. bags, containers, filters etc) is also increasing. A key driver for that growth is the fact that SU consumables come pre-sterilized and ready-to-use, making step and changeover from one product to another much quicker and easier. Single-use systems enhance flexibility, scalability and efficiency. Single-use facilities boast the benefits of shorter facility development and deployment timeframes.
However stainless steel is expected to remain in use for some time. Stainless steel retains its relevance for certain products. Universal block-buster, such as treatments for cancer, diabetes and others in which large volume is required, will keep on being produced in stainless steel. Stainless steel bioreactors can support manufacturers across a variety of higher volumes, including those between 10.000 and 20.000 L. Though stainless steel has a higher upfront costs, if you have a blockbuster drug, it could provide more long terms savings because of its durability.
Is there a best choice then? Choice is totally dependent on each biomanufacturer’s unique scenario. Factors to consider can include molecule type, cell density, demand stage (pre-clinical, early phase, late-phase, clinical, commercial etc), patient population, quantity of product,, single-product versus multi-product facility and new versus existing facility. All these together (and more) will help make a best choice from both an economical and environmental perspective.
In conclusion, a comprehensive evaluation always has to be made at design onset.