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Automated Osmometry



Product: Advanced 20G high-throughput osmometer

Applications: Cell culture process development and optimization

Features: The Advanced 20G high-throughput osmometer combines state-of-the art osmometry technology and robotics within a parallel sample processing scheme. Samples can be analyzed in a 96-well format within 35 minutes with the same accuracy as stand-alone osmometers. The 20G system supports osmolality testing in even the most demanding cell culture process development schemes in the biopharmaceutical industry.

Contact Advanced Instruments Inc.

www.aicompanies.com

UV Calibration



Product: Calibration accessories for Optek AF16/AF26 sensors and AS16 probes

Applications: Visible (Vis) and near-infrared (NIR) analyzer calibration

Features: Optek delivers new, nonintrusive Vis and NIR calibration filters traceable to NIST. They test photometric accuracy and linearity by attenuating 0.45, 0.90, and 1.80 AU of light. A unique design architecture eliminates stray light for increased accuracy, and filters absorb light throughout the Vis and NIR spectra. A unique calibration cuvette allows nonintrusive introduction of product samples or liquid calibration standards for direct comparison with a laboratory spectrophotometer.

Contact optek-Danulat

www.optek.com

Microscale Cell Culture

Product: CompacT SelecT Advanced Plating Module (APM)

Applications: Cell culture optimization and product testing

Features: This alternative to the established CompacT SelecT system increases plating flexibility to enable consistent, high-quality cell plates ready for use in assay development, cell-based screening, and toxicity studies. The system also supports maintenance of cells and media exchange in six-well and 24-well plate formats. A flexible plating system automates plate-based applications traditionally requiring labor-intensive feeding regimes. With control of temperature, CO2, and humidity, the incubator with “SelFeeder” liquid-handling unit reduces damage to cell layers.

Contact The Automation Partnership

www.automationpartnership.com

Cell Culture Media

Product: Animal-component–free cell culture media

Applications: Biopharmaceutical and vaccine production

Features: Irvine Scientific, a member of JX Holdings group, is opening a new 1,720-m2 industrial cell culture media production facility in Tokyo, Japan. It will manufacture animal-component–free cell culture media for production of vaccines, monoclonal antibodies, and other medicines, as well as research applications. The company is regulated and adheres to both ISO and FDA regulations. Its Tokyo facility expands existing capacity in California to increase the stability of product supply and serve customers in Asia. It expects to begin delivering products in March 2011.

Contact Irvine Scientific

www.irvinesci.com

Clinical Testing

Service: Clinical trials management

Applications: Product development

Features: Advanced Clinical introduces the “Industry Leading R&D Performance” (ILRDP) framework for accelerating clinical trials. It uses codified delivery methods, tools, techniques, and intellectual property assets to speed the delivery of a clinical study at the lowest total cost of ownership and with the highest probability of success. The company provides consulting services, strategic contract research, talent managment, and technological solutions to drug and medical device companies. It now provides “end-to-end” service for clinical trials, evaluating risks and providing mitigation techniques for them.

Contact Advanced Clinical

www.advancedclinical.com

Depth Filtration

Product: Supra AKS depth filters

Applications: Biopharmaceutical purification

Features: Intermediate-size Supra AKS depth filter cartridges give process developers scale-up options when using Seitz AKS immobilized activated carbon depth filter media. These modular filters can be quickly installed into standard sanitary-style cartridge housings. They fill the gap between small Supracap 60 capsules and larger-scale Supradisc I modules. The mid-scale cartridges can be used to confirm small-scale results and for process scales up to ~100 L. They come in 10-in, 20-in, and 30-in and feature a unique upstream–downstream separator and Code 7 housing adaptor. The filters can withstand 80°C and 35 psi.

Contact Pall Life Sciences

www.pall.com

Membrane Filtration



Literature: Brochures for STyLUX polyethersulfone (PES), Chemdyne polypropylene (PP), and Ultradyne PTFE membrane filters

Applications: Downstream processing

Features: Brochures feature flow-chart data to provide sizing guidelines. Typical applications are presented for hydrophilic STyLUX filters and hydrophobic Chemdyne and Ultradyne filters. Each brochure provides a detailed ordering matrix to walk end users through the selection of absolute micrometer ratings, filter cartridge length, and end-cap configurations with O-ring seal ma
terials.

Contact Meissner Filtration Products

Inc. www.meissner.com

Product Packaging



Service: Vetter secondary packaging

Applications: Fill and finish

Features: As an independent international specialist in aseptic fill and finish, Vetter offers a number of options for final assembly and packaging of pharmaceutical and biotech products: both semi- and fully automated secondary packaging; high standards of cosmetic integrity; and assembly of pens, autoinjectors, and safety devices. The service also offers labeling, blistering, and cartoning with package inserts and case packing.

Contact Vetter Pharma International

GmbH www.vetter-pharma.com

Tubing Clamps



Product: BioClamps

Applications: Single-use bioprocessing

Features: BioPure’s redesigned tubing clamps use a cable-tie retaining ring on the wing nut to facilitate tamper evidence. Pronounced internal and external edges have been removed, and size identification has been added to each component. Lot number identification is improved, and patent numbers have been added where space allows. With the BioValve range of products, these clamps are designed to ensure secure and convenient processing and media transport.

Contact BioPure Technology Ltd.

www.biopuretech.com

Chromatography

Product: ÄKTAready system

Applications: Chromatography steps in downstream processing

Features: This liquid chromatography system is built for process scale-up and production for early clinical phases. It operates with ready-to-use, disposable flow paths available separately in high- and low-flow kits. They eliminate the need for cleaning (and associated validation) between products/batches. Replacing flow paths between projects is fast, and cross-contamination risk is removed when the system is used with ReadyToProcess columns. The ÄKTAready system meets all GLP and CGMP demands for drug development and full-scale production. It is controlled by UNICORN software.

Contact GE Healthcare Bio-Sciences

AB www.gelifesciences.com

Cellular Analysis

Product: Streptamer technology

Applications: Bioanalysis

Features: IBA GmbH and Beckman Coulter, Inc. have partnered for exclusive North American distrubution of IBA’s Streptamer product portfolio for T cell staining and isolation. Streptamer technology allows for antigen-specific staining and isolation of naturally occurring T cells with reversible reagents that do not affect cell expression, trigger activation, or induce functional changes. Because all reagents used for staining or isolation can be removed with biotin, the isolated T cells remain uncompromised and retain phenotypic and functional characteristics undistinguishable from naturally occurring cells.

Contact Beckman Coulter, Inc.

www.beckmancoulter.com

IBA GmbH www.iba-go.com

Cation Exchange

Product: ProRes-S media

Applications: Chromatography steps in downstream processing

Features: Millipore’s ProRes-S semirigid cation-exchange resin rounds out the company’s downstream purification portfolio for MAbs and other proteins. Developed jointly with the Dow Chemical Company, ProRes-S media offers increased throughput in a smaller manufacturing footprint than previous cation exchangers. This semirigid resin works in a broader operating window over a wider range of conductivities, is optimized for resolving difficult impurities, and allows higher bed packing.

Contact Millipore Corporation

www.millipore.com

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