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May 15, 2010 (Vol. 30, No. 10)

Single Use Becoming an Established Tool

Vendors' Attention to Users' Requirements and Familiarity Are Driving Increased Implementation

  • Two New Platforms

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    Sartorius Stedim Biotech’s FlexAct platform is a centralized platform that enables the design and deployment of single-use equipment across biomanufacturing.

    Integrating disposable bioprocess components requires more than simply hooking them together aseptically. The importance of configurability, flexibility, and speed will be the theme of a presentation by Thomas Paust, global director of marketing for integrated solutions at Sartorius Stedim Biotech. Paust will discuss the advantages of FlexAct, a centralized platform that enables the design and deployment of single-use equipment across biomanufacturing.

    FlexAct consists of a central module on a portable skid that incorporates a touchpad-controlled user interface or central operating module borrowed from the company’s BioStat® bioreactors and Sartoflow® crossflow filtration units, plus a pump, sensors, and controllers. FlexAct allows system design without having to design everything from scratch, Paust says.

    “Think of FlexAct as a workstation that organizes the components and enables the first steps of automation.”

    Sartorius Stedim Biotech’s first FlexAct unit operation will be buffer prep, followed by media preparation, cell harvest, ultrafiltration/diafiltration, virus removal, virus inactivation, virus adsorption, polishing, form/fill, and form/transfer.

    Sartorius Stedim Biotech currently covers all these unit operations but not at this level of integration. “The other important component here is standardization,” Paust notes. “Today we see a lot of engineered systems customized for specific processes. This creates advantages for bioprocessors who are able to work this way. But there are some disadvantages as well, such as delivery times, the need for specific components of specific designs, and connectivity.”

    Similarly, GE Healthcare’s ReadyCircuits single-use configuration platform will be the subject of a presentation by GE senior product manager Karen Green. As part of the company’s ReadyToProcess™ biomanufacturing platform, ReadyCircuits allows plug-and-play assembly of self-contained, fully disposable unit operations such as buffer filtration and tangential flow filtration.

    GE is constructing an online configuration tool that will allow purchasers to specify bags, filters, tubing, and other components through a graphical interface. Components will arrive fully assembled and presanitized. “Validation is built in,” Green says.

    ReadyCircuits will provide systems for upstream and downstream processing, for example normal flow and crossflow filtration, purification and polishing column chromatography, cell harvesting, and, of course, fermentation and cell culture based on the Wave bioreactor product line.

    ReadyCircuits arose from customer feedback, Green explains. “Users were looking for a fast, flexible solution of disposable unit operations that could be assembled Lego-style.” GE already sells hundreds of sub-assemblies. “With the online tool, users will be able to design one from their own concept, or we can provide them with a head start consisting of a starter kit that they can then modify.”

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