AAPS Biotech Exhibitor Showcase

Biomass Monitor
Applikon is now a distributor of BugLab LLC’s BE2100, a non-invasive, real time monitor for biomass applications in the biotechnology market. Using BugLab’s BE2100 technology eliminates fouling and sampling errors, allowing freedom from coming in the laboratory during off hours to take biomass measurements. Bug Lab’s BE2100 performs automated, continuous, real-time optical density (OD) measurements of biomass for algal, fermentation, and cell culture applications. It is designed for use in both research laboratory and industrial environments and is used with a variety of different fermenter and bioreactor vessel types. Because no immersion port is required, it avoids fouling and contamination, while providing a wide linear range (from <0.1 to >300 OD units). Applikon Biotechnology, 650.578.1396, http://www.applikon.com.

ULT –80°C Freezers
New Brunswick Scientific’s Ultra-Low Temperature (ULT) –80°C laboratory freezers consume roughly half the power of freezers of similar size, saving thousands of dollars in energy consumption over the life of the freezer. Space-saving Innova models feature specialized low-temperature seals on inner and outer doors, and ice-proof inner door latches to prevent cold air loss. An under-counter model is also offered for convenient in-laboratory storage. New Brunswick Scientific, 877.723.3319, http://www.nbs.com/b3.

AAPS Biotech Booth #404
Biologics and Injectables Manufacturing Facility
Althea Technologies, Inc., has opened a state-of-the-art, commercial-scale cGMP manufacturing facility in San Diego, CA. The decision to create expanded capacity was brought about by the need in the region to keep pace with the growing needs of the industry to outsource biological and injectable product manufacturing. A significant segment of the biotechnology industry consists of companies focused on R&D, that do not have the expertise or capital to invest in a manufacturing facility. Manufacturers, such as Althea, allow biotech companies to keep focus on their core competence in R&D. Among the features of the new cGMP facility are its compliance with both US and European manufacturing regulations and its state-of-the-art building management system that ensures a sterile manufacturing environment. Althea Technologies, Inc., 858.882.0220, http://www.altheatech.com.

cGMP Facility for bHA Production
Novozymes Biopharma has begun construction of a new cGMP facility at the company’s existing site in Tianjin, China, that will produce its novel form of Bacillus-based hyaluronic acid (bHA), HyaCare, to pharmaceutical grade Q7, paving the way for use in medical devices and pharmaceutical applications. Novozymes Biopharma is setting a new benchmark for the production of HA for applications from ophthalmic surgery to drug delivery with the launch of large-scale GMP Q7 production planned for Q1, 2011. HyaCare is produced using Novozymes Biopharma’s fermentation and purification technology. The HyaCare process is completely free of animal-derived components and produced without the use of organic solvents. Novozymes Biopharma, +45 44 46 00 00, http://biopharma.novozymes.com.

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.

AAPS Biotech Booth #623
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. Vetter’s WFI syringe combines its 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, http://www.vetter-pharma.com.

AAPS Biotech Booth #617
Cell Culture
CellPrime rAlbumin AF-G is a recombinant human serum albumin, specifically engineered to provide an animal-free alternative to current serum-derived human or bovine albumin. Suitable for both commercial-and research-scale mammalian cell culture, it offers all of the benefits of native albumin without the regulatory challenges associated with animal-derived sources. CellPrime rAlbumin AF-G helps you to move beyond chemically defined media without compromising on performance or safety. It is manufactured by Novozymes and sold exclusively through Millipore. Millipore, 800.645.5476, http://www.millipore.com/cellprime.

Raw Water Filtration
With Ultrastil TW, Christ introduces a ready-to-connect membrane filtration plant for the removal of suspended solids from aqueous solutions. The system can be installed upstream of reverse osmosis and electrodeionization units and ensures a silt density index of <3. The ultrafiltration membranes installed have a pore diameter of approximately 0.01 µm, ensuring a cut-off of 100 kD for retention. Christ Water Technology Group, +41 61 755 8111, http://www.christwater.com.

AAPS Biotech Booth #617
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, and Lynx sterile connectors, and Mobius single-use mixing and storage systems. The process-ready hardware systems are ergonomically designed for faster set up, adaptability to changing process needs, and minimized operator error risk. Millipore Corporation, 800.548.7853, http://www.millipore.com.

Ultra LC/MS Solvents
The J.T.Baker ULTRA Liquid Chromatography/Mass Spectrometry (LC/MS) solvents product line from Mallinckrodt Baker is designed to meet the needs of the most demanding ultra-high pressure liquid chromatography (UHPLC) and mass spectrometry research and analytical testing applications such as proteomics, drug discovery, pharmacokinetics, and clinical research. The ULTRA LC/MS solvents extend the useful life of UHPLC columns by controlling trace metal impurities, organic impurities, and particle levels. The solvents are filtered through 0.1 m filters that provide extremely low particle counts, and are packaged in 1 L borosilicate bottles that minimize leaching of trace metal impurities. Mallinckrodt Baker, 888.777.1433, http://www.mallbaker.com/lcms.

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, which 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. Bio-Rad Laboratories, Inc., 510.724.7000, http://www.bio-rad.com.