Global Marketplace November 2009

Disposable Component ID

Product: Single-use tubing and molding components

Applications: Biopharmaceutical manufacturing

Features: The industry wants reliable identification of components in single-use products. AdvantaPure addresses that with identification solutions that include the AdvantaLabel molded silicone labeling system, PET process-equipment tracking, and GammaTag gamma-irradiation–sterilizable RFID tags. The new DocuLink identification product (patent pending) will soon be launched to provide users a way to reference batch, lot, and validation documentation after installation of a molded-silicone manifold.

Contact AdvantaPure www.advantapure.com

Hydrophobic Interaction

Product: HIC membrane adsorber

Applications: Removal of hydrophobic contaminants

Features: Sartorius Stedim Biotech has launched the first commercially available membrane adsorber for hydrophobic interaction chromatography (HIC). Sartobind Phenyl membrane adsorbers allow increased flow rates to ensure faster processes and can be used for upgrading purification and polishing of therapeutic proteins. Sartobind Phenyl provides the advantages of an HIC ligand adsorber, while showing the specificity and behavior of a conventional HIC matrix.

Contact Sartorius Stedim Biotech www.sartorius-stedim.com

Automated Screening

Product: Tecan Freedom EVO liquid handling workstation

Applications: Screening for binding capacity, wash and elution conditions, and chromatography media

Features: Prefilled PreDictor 96-well plates from GE Healthcare work with a Tecan Freedom EVO liquid handling workstation to reduce experimental time from weeks to hours with significantly lowered sample consumption. Together they provide reliable methods for high-throughput screening of chromatographic conditions.

Contact Tecan Group Ltd. www.tecan.com/parallel

New CMO Facility

Service: Contract final product manufacturing

Features: A CMO headquartered in Ravensburg, Germany, is opening a US manufacturing site at the Illinois Science and Technology Park in Skokie, IL. The company supports pharmaceutical and biotechnology clients in every phase of production, from product development to successful product launches and commercial manufacturing. With its global experience with the FDA, the EMEA, and other regulatory authorities, the company is known as a worldwide specialist in aseptic production of prefilled syringes, cartridges, and vials.

Contact Vetter www.vetter-pharma.com

Standardized DNA Assay

Product: CometAssay system

Applications: Detection of DNA damage in cultured cells

Features: Amsbio offers a complete assay system for direct detection of DNA damage in cells using CometSlide multiwell slides, reagents, control cells, and an electrophoresis unit. This assay is the only direct method for detecting DNA damage in cells. It is used in cancer research, in genotoxicity studies on environmental mutagens, and for screening compounds in development of cancer therapeutics. Based on single-cell gel electrophoresis in a controlled pH environment, the assay examines and measures the integrity of stained nuclear DNA.

Contact Amsbio www.amsbio.com

Noninvasive Live Cell Imaging

Product: Celigo cytometry system

Application: Cellular analysis, cell culture maintenance, toxicity assays, and so on

Features: The Celigo benchtop cytometer provides speed, flexibility, and precision to meet all live cell imaging needs. Brightfield and multicolor fluorescence modules and analysis software provide detailed cellular and subcellular data on individual adherent or nonadherent cells in microplate wells. The system performs a range of real-time and end-point assays, and its small footprint conserves premium research space. It can analyze cells nondestructively, thus reducing the risk of cell damage and contamination, and ccan provide label-free analysis of live cells as well as fluorescence cellular analysis.

Contact Cyntellect, Inc. www.cyntellect.com.

Optimal Cell Growth

Product: Hollow-fiber bioreactors

Applications: Perfusion cell culture

Features: CellMax hollow-fiber bioreactors provide a three dimensional space for in vitro cell culture. Hollow fibers are tubular membranes with pore sizes ranging from 10 kD to 0.3 µm. Cells grow on and around the large surface area. When perfused with culture media, the hollow fibers supply oxygen and nutrients to cells while eliminating metabolic waste products. The process increases accumulation of the cell-secreted growth factors required for optimal growth and uses less culture medium than other methods. Cultures can be sustained for six months or more with high production yields and titers.

Contact Spectrum Labs www.spectrapor.com/cell/MaxCarts.html

Stem-Cell Culture

Product: Rotary cell culture system

Applications: Stem-cell engineering

Features: The Rotary cell culture system is a three-dimensional cell culture bioreactor capable of expanding/differentiating embryonic, cord blood, and bone marrow stem cells. Applications include bone tissue engineering, neural stem cell differentiation, engineering cardiac and cartilage tissue, and production of embryoid bodies. Each bioreactor consists of a horizontally rotated culture vessel oxygenated by a flat, silicone-rubber gas transfer membrane (high aspect ratio vessel) or a coaxial oxygenator in its center (slow turning lateral vessel). Cells experience minimal mechanical stresses and high mass transport of nutrients and oxygen.

Contact Synthecon Inc. www.synthecon.com/products/autoclaveable.htm

Disposable Assemblies

Product: One-Touch single-use fluid path assemblies

Applications: Critical bioprocess applications

Features: Meissner’s One-Touch disposable fluid path assemblies can be customized to user requirements and include dynamic combinations of connectivity, tubing, and other components to provide needed functionality. Fluid paths can be integrated with filter capsules in a selection of surface areas, end-connection configurations, and media (including PES/PVDF membranes for sterilization) or with depth media for clarification. Assemblies are supplied gamma-irradiated for sterility and fully documented with prequalified components.

Contact Meissner Filtration Products, Inc. www.meissner.com

Robotic Handling

Product: ABgene Diamond Ultra PCR plate

Applications: High-throughput PCR

Features: This PCR plate is warp resistant, ensuring consistent dimensions during thermal cycling and eliminating problems when removing plates. The polymer strength contributes to maintaining seal integrity, reducing evaporation, and ensuring consistent performance. The well design (combined with the polymer properties) lessens splash-back during pipetting steps to improve liquid handling. Each well has uniform, thin walls for rapid and consistent heat transfer and a “diamond-like” clarity for quick and easy visual plate checks.

Contact Thermo Fisher Scientific www.thermo.com/abgene

Lyophilization

Product: LyoStar freeze dryer

Applications: Protein-based therapeutics

Features: For scientists wanting to streamline the development of freeze-dry cycles for protein therapeutics, SP Industries offers its LyoStar freeze dryer with SMART freeze-dryer technology. Integrating these technologies provides maximum programming flexibility and product protection, whether for vials, bulk trays, 96-well plates, or syringes. This freeze-dryer is designed for ease of use and built like a production model, but it is pilot-plant sized. It provides shelf mapping, fast shelf freezing, and vial stoppering to reduce average formulation development cycle times.

Contact SP Industries www.spindustries.com

Clinical Testing

Service: Monitor View platform

Applications: Clinical trials management

Features: Clinical CRO Health Decisions offers a new phase of its HD360° trial management platform called Monitor View. This module reduces monitor time and travel expense — costs that account for ≥80% of a typical trial budget. Monitors from both Health Decisions and sponsor companies can perform their tasks and access information at a glance through a simplified, customizable Internet environment. User-friendly search and reporting tools and automated resolution of some queries ensure greater control over investigator site performance and data trends to produce fast, accurate results without wasting resources.

Contact Health Decisions www.healthdec.com