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Mar 1, 2009 (Vol. 29, No. 5)

Quest for Fully Disposable Process Stream

Flexible Manufacturing that Easily Transitions between Products and Projects Is Coveted

  • Seeking Standardization

    Click Image To Enlarge +
    An engineer performs mixing studies in the XDR-2000 disposable bioreactor in Xcellerex’ pilot plant.

    A lack of standardization around disposable ports and connectors is “a shared frustration” in the bioprocess industry, remarks Geoffrey Hodge, managing director of technology development at Xcellerex. CMOs and other producers can try to standardize their systems on a few select tubing sizes or rely on customized products, but it is more likely that they will have to work with a dozen or more manufacturers of disposable products to meet all of their needs.

    In response to demand for larger-volume processing, Millipore introduced the 1-inch Lynx® ST (Steam-To) connector, designed for the transfer of sterile fluids between steamable, hard-piped processing systems and sterilized disposable flow paths. Also new to the company’s Mobius®  family of single-use bioprocessing solutions is the MIX500 disposable mixing system, which contains a 500 L carrier, a single-use magnetically driven impeller inside a disposable Mobius process container, and an electronic drive unit. Mobius single-use mixing systems also come in 100 L and 200 L volumes.

    GE Healthcare offers its ReadyMate™ line of genderless disposable connectors. By eliminating the need to stock both male and female connectors, inventories can be reduced by half, notes Darby. “Furthermore, the range of flow path sizes provides scientists with more flexibility in line tubing reductions or increases by using the same ingenuous aseptic connector,” he says.

    In addition to the direct cost savings possible using disposable components, another way to look at their economic impact is how they affect a company’s productivity. With a quicker turnover rate from batch to batch and product to product, a company can move more products through a facility, advance more products into clinical trials, and shorten the time to market.

    It is not unrealistic to realize a 20–30% increase in the number of projects a facility can manage with a switch to disposables, says Darby. “An extra year of a drug on the market has a considerable economic value,” he adds.

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