Microbial Culture Market
Until recently, Xcellerex focused its capabilities on single-use mammalian cell culture technology, but the company has expanded into the microbial culture market with the launch of a 30 L fermentor; a 200 L fermentor is in the prototype stage of development.
In addition to strong interest in the new small-scale, disposable fermentor, the company reports growing demand for its mammalian cell systems, according to Geoff Hodge, vp of process technology and development. Xcellerex recently introduced 2,000 L and 50 L units, rounding out the range of its bioreactor product line.
Xcellerex developed its biomolecule manufacturing platform based on the modular FlexFactor™ systems and XDR single-use bioreactors. The company recently sold a FlexFactory production line to Crucell for use in its manufacturing facility in Leiden, The Netherlands, for vaccine and monoclonal antibody production.
According to Andrew Bulpin, Ph.D., vp for upstream processing at Millipore, “single-use stirred tank bioreactors have been gaining favor for pilot- up to commercial-scale production in volumes ranging from 50–2,000 L. Disposable technologies eliminate sterilize-in-place/clean-in-place steps, offer multipurpose and process flexibility, and enable streamlined validation and reductions in overall turnaround times. “Single-use STRs can be used within a fully disposable or hybrid disposable-reusable production scheme and are ideally suited for mid-scale (1,000–2,000 L) cGMP manufacturing,” adds Dr. Bulpin.
Millipore developed the Mobius® CellReady 3L stirred-tank bioreactor, which was launched at “ESACT,” in partnership with Applikon Biotechnology. Designed for cell culture applications, the unit operates with existing Applikon motors and controllers.
All parts of the rigid 1/4-inch thick reactor vessels, including the plastic head plate, are disposable. Larger size vessels will follow, according to Dr. Bulpin. The units are delivered preassembled and gamma irradiated and contain multiple fluid addition ports above and below the liquid level and an integrated harvest line at the bottom of the vessel to ensure sterile transfer and full removal of contents.
Applikon’s bioprocessing product line, which includes the AppliFlex line of single-use bioreactors, is available with 10 L, 20 L, or 50 L bags, and monitors pH, temperature, and dissolved oxygen using a choice of disposable or reuseable sensors. In the first quarter of 2010, the company will introduce a new form of shaker that uses acoustic energy to achieve high oxygen transfer rates and enhanced expression levels. For the biofuels market, Applikon recently introduced a six-pack, 500 mL fermentation system designed for feedstock selection applications.