BIO 2009 Product Focus

Clean Steam Products
Nicholson Steam Trap, a division of Spence Engineering, has released a line of Clean Steam Products. Nicholson uses welded stainless-steel bellows construction for performance and durability. Nicholson clean steam products are used for clean-in-place and steam-in-place system condensate drainage, process vessel sterilization, sterilizers, autoclaves, and pharmaceutical and biotechnology process equipment. Spence Engineering Company, 845.778.5566, http://www.spenceengineering.com.

Microbial Air Sampler
The Coriolis air sampler, developed by Bertin Technologies, relies on a patented technology, consisting in cyclone-type operation to concentrate airborne biological particles into a liquid media. It has been validated for cleanroom air monitoring and can collect airborne microorganisms such as viruses, bacteria, and mold. According to ISO 14698 recommendations, biological and physical efficiency of the technology have been validated for the collection of bioparticle sizes greater than 0.5 µm. The liquid sample gives access to cultivable, viable, and noncultivable flora because of its compatibility with the whole range of microbiological analysis including immunoassays, PCR, and flow cytometry. Bertin Technologies, 00 33 139 306 040, http://www.coriolis-airsampler.com.

BIO Booth #5415
Magnetic Bead-Based Human and Mouse Cytokine Assays
Bio-Rad Laboratories, Inc., has launched Bio-Plex Pro magnetic bead-based human and mouse cytokine assays. Magnetic bead-based immunoassays offer full automation previously unavailable with suspension bead arrays. Bio-Plex Pro magnetic bead-based human and mouse cytokine assays are multiplex assays for the detection of multiple biomarkers in a single experiment, using as little as 12.5 microliters of serum, plasma, or other body fluids. Magnetic bead-based assays enable magnetic separation during wash steps by using a fully automated magnetic bead washer, the Bio-Plex Pro Wash Station, for results within 3–4 minutes. Bio-Rad Laboratories, Inc., 510.724.7000, http://www.bio-rad.com/bio-plex.

1.3–14 L Fermenter/Bioreactor
New Brunswick Scientific introduces the BioFlo/CelliGen 115, a fermenter and bioreactor system in 1.3–14 L capacities. Its compact, benchtop control station features a built-in color touchscreen interface, pumps, configurable gas flow controllers, pH/DO, and foam/level controllers. This completely integrated design enables set up in under a half hour. Control screens are intuitive to use and capable of regulating up to three independent systems. Numerous options for gas flow, impellers, and vessels make the BioFlo/CelliGen 115 ideally suited to a wide range of applications including teaching laboratories, biotech and biofuels facilities, R&D and testing, food and beverage manufacturing, and pharmaceutical research. New Brunswick Scientific, 877.723.3319, http://www.nbsc.com/B5F.

BIO Booth #5319
Mammalian Cell Culture Facility
Sandoz’s fully integrated 13, 000-L production line for cell-culture–derived biopharmaceuticals and antibodies in Schaftenau, Austria is an extension to its existing cell culture facility, which has been in operation since 2004. The new plant has a highly flexible, modular design and comprises one 100-L line used for development and technology transfer, one production line with a capacity of 3,000 L, and two independent 13,000-L lines. The fermentation units are operated in fed-batch mode and are linked to fully equipped, separated downstream processing lines. All facilities are designed as multipurpose plants, enabling maximum flexibility in capacity use. The facilities have been designed in close contact with regulatory authorities and meet the latest cGMP requirements. Sandoz Biopharmaceuticals, +49 (0) 8024 476-0, http://www.sandoz.com.

Modular Cleanrooms
Terra Universal’s BioSafe Modular cleanrooms meet cleanliness requirements to Class 10/ISO 3 at a fraction of the cost of conventional rooms. Their ultra-smooth stainless or powder-coated steel surfaces eliminate cracks that harbor microbes and other contaminants. Rounded corners simplify cleaning. Accessories include A/C, pass-throughs, and furnishings. Terra Universal, 714.578.6000, http://www.terrauniversal.com.

Single-Use Processing Systems
The four Mobius FlexReady Solutions from Millipore Corporation are made up of Flexware single-use filter assemblies and process-ready hardware systems optimized for clarification, media and buffer preparation, tangential flow filtration (TFF), and virus filtration unit operations. The pre-assembled, pre-tested Flexware assemblies include Millipore technologies, such as Millistak+ Pod filters, Pellicon 3 TFF cassettes, Viresolve Pro parvovirus removal filters, Millipore Express sterilizing-grade filters, Lynx sterile connectors, and Mobius single-use mixing and storage systems. The hardware systems are ergonomically designed for adaptability to changing process needs, and minimized operator error risk. Millipore Corporation, 800.548.7853, http://www.millipore.com.

Single-Use Bioreactor
ATMI’s Nucleo single-use bioreactor was developed to provide a turnkey solution to cell culturists as a next-generation alternative to stainless steel bioreactors and existing single-use bioreactors, without the need for extended validations. Nucleo is well suited to laboratory environments, process development centers, clinical material supply and flexible GMP manufacturing. The Nucleo bioreactor vessel is a single-use bag (ATMI) integrating an internal paddle mixing and sparger system (ATMI). The bag, paddle, and fittings are single-use. The paddle is enclosed in a medical grade ULDPE sleeve with the same contact material as the bag itself, and is coupled on top of the vessel with the mechanical mixing head. ATMI LifeSciences, 952.942.0855, http://www.atmi-lifesciences.com.

BIO Booth #5307
Single-Use Filter Capsule System
The Pall Stax single-use depth filter platform helps reduce labor time and eliminates equipment cleaning expenses and cleaning validation requirements incurred by biopharmaceutical manufacturers with traditional plate and frame depth filtration systems. The platform can be anchored to the floor or placed on casters for easy mobility. Its compact vertical design reduces floor space requirements. The Pall Stax system is comprised of interchangeable single-use depth filter capsules housed in a stainless steel chassis that can be managed easily by a single operator. The new platform uses Pall’s cellulose-based Seitz high performance depth filter media and its second generation Supradisc II dual drainage plate modular design to encapsulate the media. Pall Life Sciences, 800.717.7255, http://www.pall.com/biopharm.

BIO Booth #4811
Disposable Mixing System
The XDM Quad single-use mixing system from Xcellerex is designed for fast, convenient mixing of buffer, media, product, and other process fluids. The single-use design eliminates the hassle, cost and delays of steam-in-place and clean-in-place, and cleaning validation, resulting in more efficient processing and rapid batch-to-batch turnover time. Born out of Xcellerex’s experience in single-use biomanufacturing, the XDM Quad system has convenient features that simplify day-to-day process applications. These systems are scalable and are available in 100, 200, 500 and 1,000 L sizes. Xcellerex, Inc., 866.923.5537, http://www.xcellerex.com/mix.

WFI Syringes
If your product requires pre-filled water for injection (WFI) syringes, Vetter has the solution and the value-added benefits to support end-user convenience for reconstituting lyophilized products. Our WFI syringe combines Vetter’s experience in providing aseptically prefilled solutions with the quality of West’s primary packaging components. Vetter can manage all of your manufacturing needs from start to finish. With Vetter, you can focus your products while we help to manage your manufacturing processes. Vetter works directly with your team to provide you with a turnkey manufacturing solution. This includes validation and stability data for your WFI applications. Vetter Pharma International, +49 0 751 3700 0, www.vetter-pharma.com.