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10 BioPharm International eBook June 2019 Single-Use Systems Supply Chain New Strategies for Managing Single-Use Components Redundancy should be built into the supply chain. S i n g l e - u s e s y s t e m s ( S U S ) a r e g a i n i n g w idespread adopt ion b ecause t hey ca n provide a more flexible and cost-effective approach to biopharmaceutical manufactur- ing compared to conventional stainless-steel equipment. As SUS have increasingly been imple- mented in GMP drug production, supply-chain assur- ance for SUS materials, components, and assemblies has become even more important. As with other areas of the industry, dual-sourcing and redundant manu- facturing capabilities are crucial in a single-use supply chain strategy. However, these tenets of supply-chain management are often misapplied and undervalued, leading to potential risk that can result in delays or even stoppages in critical drug production. SECURING THE SUPPLY-CHAIN Production of SUS requires a variety of components, such as thermoset or thermoplastic elastomer tubing, filters, connectors, and sensors, to build complete assemblies. The industry has long relied on a dual- or multiple-sourcing model, in which a drug manufac- turing company may traditionally provide drawings for an assembly or component and request bids from two or more separate vendors to ensure redundancy for supply chain security. This approach has some sig- nificant limitations for a variety of reasons. krunja - TIMOTHY KORWAN,, is a director of new product development, and JAY HARP,, is single-use product manager, both at Avantor. TIMOTHY KORWAN AND JAY HARP

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