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Bioprocessing es identified as high-risk, explained Dr. Killian. Similarly, they may be able to limit the scope of the studies required by comparing the results of some initial tests to established standards and use these quick evaluations to define what areas require more extensive data collection and analysis. Downstream Adoption Is Looking Up Unlike for the single-use bag systems devel- oped for upstream buffer preparation, mixing, and storage, and designed to replace conven- tional glass and stainless steel bioreactors and fermentors, when it comes to downstream pro- cessing systems, "single-use" may not mean in- tended for disposal after a single run. "We like to call it 'single-use, batch-dedicat- ed,' or 'single-batch,'" explained Makowiecki. "Prepacked does not mean single-use," emphasized Paul Lynch, production man- ager for Life Technologies' (www.lifetech nologies.com) prepacked Poros® chroma- tography resins. The main advantage of pre- packed columns is time savings, as they are ready to be dropped into a process without the need for validation. "They save about 80% of the set-up time," Lynch said, as well as the associated overhead of personnel needed to pack and validate the column. At the June conference in San Francisco, Richard Garretson, business development manager at Life Technologies, led a work- shop in which he described the advantages of the company's GoPure™ columns prepacked with POROS chromatography resins. Garretson compared prepacked columns to disposable membrane absorbers, which can be used in place of anion exchange chromatogra- phy, for flow-through polishing of monoclonal antibody preparations to remove DNA, virus- es, and host-cell proteins. The high mass trans- fer capability of the POROS prepacked resin allows for high flow rates, short bed lengths, and small column sizes. "The resin has the same sort of mass trans- fer profile as a membrane absorber," said Gar- retson. Once users have selected the ideal col- umn bed length for the separation they want to achieve, they can then increase or decrease the diameter of the column as desired for scale-up or scale-down, Garretson explained. In contrast, scale-down—for process mod- eling, process characterization, and viral clear- ance studies, for example—is "problematic with filters," he added, due to more limited availability of membrane sizes. In terms of single-use capability, the pre- packed chromatography resin, like a tradi- tional self-packed column, can be re-used multiple times or replaced after a single use. It would typically be used for a single produc- tion campaign. In contrast, a functionalized filter is a consummable product intended to be disposed of after one use. Producing relatively small drug batches or material for toxicology studies or clinical trials can mean switching product streams, and thus chromatography columns, more frequently. In this scenario, the use of prepacked columns can save time and money, contended Michael Killeen, business development manager, GE Healthcare (www.gelifesciences.com). Killeen's presentation in San Francisco was entitled "'Out of the Box' Thinking for Process Chromatography." The company's ReadyToProcess™ prepacked columns can be used for multiple runs; however, the res- ins cannot be removed and repacked and are intended for use in a single campaign. When combined with GE Healthcare's ÄKTA™ ready disposable chromatogra- phy flow path, there is no need to clean or validate the system before use, pointed out Killeen. With flow rates up to 510 L/h, the systems are appropriate for pilot to small batch production. A side-by-side analysis that compares the cost of processing one batch with a pre- packed versus traditional column at pilot scale "can show significant savings," added Killeen. "If you can get ten molecules pro- duced instead of eight," that is a good value proposition for the customer." Editor's Note: As GEN went to press Eppendorf North America (www.eppendorfna. com) reported the release of the first single- use vessel to incorporate New Brunswick's proprietary packed-bed impeller system. The New Brunswick CelliGen® BLU 5L comes pre-loaded with 150 g of Fibra-Cel® disks. Color your lab MiniBio and my-Control: good looks, great performance Our colorful range of MiniBio bioreactor systems provides a true scale down of your laboratory scale bioreactors. The MiniBio systems have the same versatility as the laboratory scale bioreac- tors. This means that the MiniBio systems can be customized to fi t your demands for any process. The small volume reduces medium costs and optimizes the use of expensive bench space. 8 & ., & ) +! MiniBio and my-Control: colorful power for every lab 8 .1" / ")) 1)01." ,+#&$1. 0&,+ 8 0 % "! 0 % +! ,+0&+1,1/ 1)0&2 0&,+ 8 8 8 *) ,0 ) 2,)1*" 3&0% 1- 0, *) ,0 ) 2,)1*" 3&0% 1- 0, *) ,0 ) 2,)1*" 3&0% 1- 0, 8 ,.,/&)& head plate and inserts 8 2".) 5 ,. - .$". ". 0&,+ /- .$". ,. -,.,1/ /- .$". 8 &-/" )"! /0&..". #,. 1- 0, *&4&+$ 8 "&$%0 !'1/0 )" &*-"))"./ 1/%0,+ ,. of processes .&+" &*-"))"./ 0" $) // 2"//") +! /0 &+)"// /0"") *) 3,.(&+$ 2,)1*" *) 3,.(&+$ 2,)1*" *) 3,.(&+$ 2,)1*" 8 - )" !,3+ !"/&$+ ,##"./ " /5 / )" 1- of processes 8 ) //& ) /"+/,./ #,. .")& 8 8 / ),3 2& ,-0&,+ ) ,*-)"0" &,." "*-". 01." 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