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BIO INNOVATION NOTES more cost-effective versus single-use for commercial product manufacture (where productivity is most important, and flexibility and related changes are less significant). Despite rapid adoption of single-use systems at smaller scales, use of stainless steel is and will continue to grow, just not as rapidly. Even 10 years from now, and perhaps longer, stainless steel will remain the dominant commercial bioprocessing platform, with single-use adoption for commercial manufacture continuing to ramp up. In fact, most of the largest facilities — built in the 1980s and 1990s and commonly described with terms such as "legacy" or "dinosaurs" — are still in use and overwhelmingly provide most of the world's biopharmaceutical manufacturing capacity. Stainless-steel bioprocessing equipment, especially for commercial-scale manufacture, has changed little in recent decades. And until recently, most of the innovation has come from the processing performed in the stainless equipment. But stainless equipment manufacturers continue MAJOR TECHNOLOGICAL TRENDS DRIVING INNOVATIONS IN STAINLESS-STEEL BIOPROCESSING: Higher titers: Better cell lines and expression systems continue to increase yield, making it possible to specify stainless-steel equipment at smaller scale. Sensors: There are not only few but sometimes inadequate sensors for most relevant analytes for single-use applications. Those available are primarily for use with stainless-steel systems. So, stainless-steel systems have clear advantages in terms of providing process data. Automation/process control: Most stainless-steel facilities now have state-of-the-art, real-time process monitoring and control systems. These systems, combined with more and better sensors, PAT (process analytical technology), and other efforts to make optimal use of process data, enable better control and documentation of bioprocessing. Perfusion: Perfusion (i.e. involving retaining higher levels of cells and expressed products in bioreactors using filter pumps) or other methods such as centrifugation enable the use of even smaller bioreactors. Perfusion devices are increasingly being adopted and added to many stainless-steel facilities. Hybrid systems: Many stainless-steel facilities are slowly adapting single-use equipment into their existing facilities. This involves singleuse equipment where it provides significant or needed advantages over stainless steel, for example, single-use membrane filters. This will require specialized compatibility innovations. Business models: As yields go up, many companies with large, in-place stainless-steel facilities and unused capacity are offering manufacturing services to other companies. This is a radical change for some companies. Relatively few stainless-steel facilities have yet to be mothballed or dismantled, with most still in use. to innovate, and indications are that there will be increasing incremental improvements. For example, according to Andrew Powell, VP and GM at CRANE CPE, innovation in stainless steel bioprocessing is a primary focus. "At Saunders, we recently released our Stainless Steel S360 actuator range, and we're investing heavily in new product innovation. In the near future, I would expect to see even more substantial improvements in processes using stainless equipment." These improvements are needed, as most of the largest stainless-steel facilities are operating below capacity. Some are being converted to more adaptable multiuse facilities. In many cases, this involves radical innovation in business practices, with many of the largest and most established manufacturers now offering CMO services (e.g. GlaxoSmithKline) or concluding manufacturing agreements with other companies (e.g. MedImmune/ AstraZeneca manufacturing for Merck & Co). Thus, innovations continue to drive expanded use of stainless steel. Survey Methodology: The BioPlan annual survey of biopharmaceutical manufacturers yields a composite view and trend analysis from over 300 responsible individuals at biopharmaceutical manufacturers and CMOs in 29 countries. The methodology included over 150 direct suppliers of materials, services, and equipment to this industry. This year's study covers such issues as: new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, budgets in disposables, trends in downstream purification, quality management and control, hiring issues, and employment. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time and assesses differences in the world's major markets in the U.S. and Europe. If you want to learn more about the report, please go to bioplanassociates.com. 22 LifeScienceLeader.com November 2013