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4 BioPharm International eBook June 2019 Single-Use Systems Manufacturing Thinking Flexibly in Biomanufacturing Single-use systems may offer a suitably flexible solution to the biomanufacturing challenges of cost and time-to-market. T he global biopharmaceutical market is set to grow by a compound annual growth rate of nearly 14% over the next six years, accord- ing to market research (1). Reported drivers for this progression include an aging global population, an increase in the prevalence of chronic conditions, and an overall rise in the uptake of bio- pharmaceutical products on the global market. These complex medical products, however, can be extremely costly to manufacture, with potentially high rates of failure and difficulties encountered when trying to reach the market. One possible aide for biopharma manufacturers is to employ single-use systems (SUS) within manufacturing processes. BENEFITS OF SUS IN BIOMANUFACTURING "The benefits of using SUS are driven by the need to reduce time, cost, and complexity of reaching the market," says Alex Chatel, product manager at Univercells. "SUS allow a reduction of the batch time by removing cleaning and sterilizing steps in between batches, but also significantly reduce the validation burden and the number of required opera- tions associated with these steps." Parrish Galliher, chief technology officer–upstream at GE Healthcare Life Sciences, explains in com- parison to traditional stainless-steel facilities, and according to user reports, that SUS are tremendously impor tant in biopharmaceutical manufact uring. ShpilbergStudios - FELICITY THOMAS

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