January 1, 2009
Sample Preparation
Product: FlowCytoPrep5000 system
Applications: Cell analysis
Features: The FlowCytoPrep5000 is a biological sample preparation system designed to allow combined automated sampling, sample preparation, and realtime flow cytometric analysis. The system is appropriate for advanced cell culture monitoring and control, high-throughput screening, and handling multiple samples without manual preparation. When interfaced with a flow cytometer, the system enables fully automated operation including sampling, washing, fixing, staining, diluting, and injecting.
Contact MSP Corp. www.mspcorp.com
Sterile Connectors
Product: Kleenpak sterile connectors
Applications: Inoculum transfer, sampling, sterile connections, and bulk material handling
Features: These disposable connectors allow for the dry connection of two separate sterile fluid pathways while maintaining the sterile integrity of both. Connections can be made in seconds, anywhere, even outside a controlled air environment. The connectors are appropriate for inoculum transfer to reactors, sampling during fermentation or cell culture; connection of small, sterile equipment to large equipment (e.g., bioreactors); handling of bulk material in a nonsterile environment; and connection from tank to filling line.
Contact Pall Life Sciences www.pall.com
Enhanced Cell Magnification
Product: Glass cell culture and biotechnology products
Applications: Cell analysis
Features: Iwaki glass cell culture and biotechnology products offer the superior optical clarity of an ultrathin (0.175 ± 0.02 mm) and uniform glass base. They are designed to allow fluorescent measurement of live and dead cells at a higher magnification than that achievable through plastic dishes. The culture plates reduce well-to-well cross-talk and contamination.
Contact: Sterilin Limited www.sterilin.co.uk
Learning Platform
Service: www.BiopharmInstitute.com
Application: Biopharmaceuticale-learning and online engineering documents
Features: The Biopharm Institute is a Web-based portal to self-paced courses and engineering documents created and peer reviewed by industry experts. Courses provide instruction from the basics of operations and terminology for biopharmaceutical manufacturing to detailed guidance on designing and specifying bioprocess equipment. Engineering documents include work instructions to assist in designing, specifying, and purchasing equipment for biopharmaceutical applications, with particular emphasis on current regulations and standards.
Contact Biokinetics, Inc. www.BiopharmInstitute.com
Automation Integration
Product: Nexxis SDK
Applications: Task automation
Features: Nexxis SDK is a software developers’ kit that supports integration of third-party applications with the Nexxis Electronic Laboratory Notebook for routine analyses (ELN). It simplifies seamless integration between ELN and external applications. Programmers can automate a number of tasks including initiating worksheets, setting and retrieving worksheet values, and changing worksheet status. For example, an instrument calibration application could use it to integrate with ELN so that as soon as an instrument is due for calibration, it is automatically scheduled.
Contact: Labtronics Inc. www.labtronics.com
Nucleic Acid Detection
Product: MicroSEQ detection platform
Applications: Bacterial detection in manufacturing
Features: A major problem associated with culture-derived drugs is the risk of contamination by mycoplasma, which are immunogenic and potentially infectious. Traditional methods use growth on culture media to identify contaminating organisms, causing delays that can affect efficiency and costs. The MicroSEQ method uses a quantitative polymerase chain reaction (PCR) approach based on direct analysis of genetic material. The system can identify up to 90 species of mycoplasma in one assay run.
Contact: Applied Biosystems www.appliedbiosystems.com
High-Pressure, Sanitary Hose
Product: Wire-reinforced EPDM hose
Applications: Sanitary applications requiring elevated pressure and vacuum
Features: Wire-reinforced EPDM hose for applications involving pharmaceuticals and chemicals is now available. Called APEWF, it is engineered to handle a wide variety of fluids in applications requiring elevated pressure and vacuum. Performance advantages include chemical resistance properties; custom-designed construction to easily manage bends, turns, and corners; and a smooth inner surface to resist bacteria buildup. It complies with FDA standards and handles temperatures from −40 F up to 248 F (−40 C to 120 C).
Contact AdvantaPure www.advantapure.com
Long Columns
Product: AXIA columns
Applications: Liquid chromatography
Features: AXIA chromatography columns now come in 150-mm and 250-mm lengths. Their packing and hardware design eliminates bed collapse in preparative chromatography. Compared with conventional columns, these deliver a 29% efficiency increase and a decrease in standard deviation. They last longer than conventional columns — up to 1,000 cycles — and are designed to deliver high reproducibility and efficiency. Media including Luna, Gemini, and Synergi are now available in the longer columns, as are the new Lux phases for chiral separations.
Contact Phenomenex Inc. www.phenomenex.com
Assay Monitoring
Product: Electric cell-substrate impedance sensing
Applications: Cell-based assays
Features: The new ECIS Z & Zθ systems provide an automated, noninvasive means to monitor cell behavior in real time. The instruments feature state-of-the-art electronics with new software running on XP, Vista, or Macintosh operating systems. Data acquisition from both 16 and 96 well stations is rapid, multifrequency, and accurate. Applications include measurements of endothelial permeability, cell invasion, signal transduction, cell-ECM interaction, cytotoxicity, and cell proliferation.
Contact Applied BioPhysics www.biophysics.com
Controlled Production
Product: Integrated bioreactor and control system
Applications: Transition from benchtop to pilot plant production
Features: The DASGIP control system platform has been successfully integrated with the Thermo Scientific HyClone Single-Use Bioreactor (SUB) family of products. The SUB platform combines a traditional stirred-tank reactor design with the benefits of disposable bag technology. With this integration, you can transition from traditional glass benchtop bioreactors to pilot-plant applications without introducing a second or third control platform.
Contact DASGIP www.dasgip.com and Thermo Fisher Scientific www.thermofisher.com
Fill and Finish
Service: Contract fill–finish services
Applications: Filling, lyophilization, and packaging
Features: In January 2009, Irvine Pharmaceutical Services, Inc. will launch Avrio Biopharmaceuticals, which will provide a full range of formulation development and aseptic fill-and-finish services. It will focus on developing optimized production processes and providing dependable filling, lyophilization, and packaging capabilities for early phase clinical trial materials.
Contact Irvine Pharmaceutical Services, Inc. www.irvinepharma.com and Avrio Biopharmaceuticals www.avriobiopharma.com
Technical Poster
Literature: Applying Vision Technology to Calculate the Volume of Sample in a Tube
Applications: Volume and precipitate identification of samples in storage
Features: A new technical paper is available for free download from RTS covering the analysis of sample volumes in storage. It describes how RTS and a pharmaceutical partner upgraded the pharma company’s tube store with a vision system that routinely and accurately audits tubes to calculate sample volumes and identify any particulate matter.
Contact RTS www.rtslifescience.com
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