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Aug 1, 2010 (Vol. 30, No. 14)

Disposable & Reusable Manufacturing Trends

Room Exists in Growing Market for Both Single-Use and Stainless Steel Systems

  • Expanded Mixing Options

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    Applikon Biotechnology's MicroFlasks were designed to facilitate the handling and growth of large numbers of microbial strains, clonal libraries, mutant banks, and cell lines in 24- or 96-well microtiter plates.

    Sartorius Stedim Biotech continues to expand its single-use stirred tank reactor (STR) technology, which includes the Cultibag STR 50 L and 200 L systems. A 1,000 L system recently entered beta site testing. The Cultibag STR features a top-driven stirrer with magnetic coupling and is operated by the company’s Biostat® STR controller.

    Sartorius also offers the Biostat Cultibag RM in scalable working volumes from 2 L to 600 L for low-shear mixing via rocking motion. Both the STR and RM systems are available in single or twin versions, have disposable pH and dissolved oxygen sensors, and include BioPAT® MFCS/DA data-logging software.

    On the near horizon, says Maik Jornitz, group vp marketing, is the Cultibag-OBR, which will make orbital agitation technology available in a single-use system to facilitate scale-up of more sensitive cells that cannot withstand the shear forces generated in a stirred tank reactor. The orbital shaker Cultibag system will launch in the second quarter of 2010 with a 200 L and a 1,000 L unit.

    Although “single-use bioreactors are a large portion of our product portfolio, I wouldn’t say they are dominating the market,” says Jornitz. Demand remains strong for the company’s multiuse, stainless steel reactors, and Sartorius Stedim Biotech is developing larger volume versions of its Biostat in situ sterilizable bioreactors, designed for clinical material and process-development applications. The company is planning new design features for its autoclavable reactor line.

    “Most of our clients want an entire solution, not just a bioreactor.” They are looking to develop and initially scale up a process in a single-use system and then expand into a traditional stirred tank reactor. Companies need to take more of a “process view, not just a product view.”

    New Brunswick Scientific’s CelliGen® BLU stirred tank bioreactor system is available with single-use vessels in 5 L or 14 L total volume capacities. The vessels utilize a noninvasive sensor technology in which the optical pH probe and reusable DO probe each fit inside a protective sleeve to prevent them from coming in contact with the contents of the vessel. “This elegant adaptation significantly reduces turn-around time between runs and eliminates the risk of contamination due to probe insertion,” says Mike Sattan.

    “As single-use reactors are increasingly being used for scale-up of processes and production of seed cultures for manufacturing, we offer full validation packages including IQ/OQ [installation qualification and operational qualification] and material test reports for leachables and extractables needed for use in GMP applications.”

    NBS plans to introduce additional vessel sizes to the CelliGen BLU line and to add packed bed capability with its FibraCel® disks to enable operation in perfusion mode for production of secreted proteins.

    NBS and Pall recently announced a joint product development and marketing agreement to produce new disposable bioreactor systems combining the capabilities of Pall’s Allegro™ single-use biocontainer platform and the NBS CelliGen® bioprocess controller; the systems will be suitable for applications ranging from process development to cGMP manufacturing.

    In September, Applikon Biotechnology will introduce the Rambio® shaker-incubator, which utilizes ResonantAcoustic® mixing technology to achieve the high oxygenation levels required by microbial cultures to obtain high cell densities and protein-expression rates. High-intensity acoustic energy vigorously mixes the contents of the culture flasks, and the Oxy-Pump® Stopper in the mouth of each 250 mL shake flask acts like a piston for active pumping of air into the flasks.

    For small-scale parallel cultures, Applikon’s MicroFlasks contain 24 or 96 individual deep, square wells on a plate that is loaded onto a standard orbital shaker incubator. Designed for high-throughput, parallel cell culture screening, MicroFlasks “provide oxygen transfer rates equal to baffled shake flasks,” according to the company. The wells are sealed to minimize evaporation, prevent cross-contamination, and optimize gas exchange.

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