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BIO INNOVATION NOTES Innovation In Stainless-Steel Bioprocessing By Eric Langer (left), president and managing partner, and Ronald Rader, senior director, technical research, BioPlan Associates, Inc. A nyone in the biopharmaceutical industry knows that one of the most active areas of innovation in biopharmaceutical manufacturing involves advances in single-use (disposable) technology. This involves bioprocessing equipment composed of plastics rather than traditional stainless steel. Single-use devices come presterilized, ready for use and disposal after single use. In contrast, bioprocessing classically has been done using fixed, stainless-steel equipment that requires in-house cleaning and sterilization prior to each reuse. Stainless-steel systems cost more than singleuse and take longer to build. Although improvements in stainless-steel-based bioprocessing equipment have been less frequent, there will continue to be significant advances in stainless-steel-based bioprocessing. During the past 10 years, the BioPlan annual survey of biopharmaceutical manufacturers has shown that biomanufacturers have been focused on single-use devices, and demand for new stainless-steel product innovations has lagged. Figure 1 below shows the differences in demand for innovation by end users for selected singleuse devices compared with stainless steel. When asked in what areas (21 were listed) suppliers should concentrate their product development efforts, stainless-steel equipment ranked dead last at 4.9 percent. STAINLESS IS HERE TO STAY Despite this lack of industry interest in new and better stainless-steel systems, they are not likely to be replaced by single-use plastic systems. For example, single-use systems will probably never be as cost-effective at the largest manufacturing scales, such as for blockbuster antibody manufacture. Based on economics, most companies, including those using exclusively single-use devices for development, convert in later stages of development to stainless steel for cGMP commercial manufacturing. The BioPlan annual survey also shows that stainless-steel facilities currently dominate larger-scale and commercialproduct manufacture, while adoption of single-use systems remains negligible at larger scales. Currently, about 85 percent of those surveyed report manufacturing in stainless steel, and over 75 percent expressed a preference for stainless steel for new commercial manufacturing facilities. In contrast, single-use bioprocessing systems now dominate manufacturing at smaller scales, for R&D; and early trials, with about two-thirds or more of new bioprocessing systems at these scales being single-use. The benefits (e.g. flexibility) that single-use provides have yet to surpass the overall economies of scale and lower manufacturing costs of stainless-steel systems used in larger commercial manufacturing. However, in comparison with upstream bioprocessing (e.g. bioreactors), downstream bioprocessing innovations (e.g. chromatography) have been fewer and less significant, with much less adoption of single-use equipment. STAINLESS STEEL IS TRIED AND TRUE Stainless is a fully mature technology platform and remains Figure 1: Selected New Product Development Areas Of Interest Top Areas Suppliers Must Focus Development Efforts On 43.8% Disposable products: bags, connectors, etc. 39.6% Disposable products: probes, sensors, etc. Disposable product: bioreactors Stainless-steel equipment 20 LifeScienceLeader.com 34.0% 4.9% November 2013