Products, Services, and Literature March 2008

Downstream Processing

Product: SciPure 300 GMP production platform

Applications: Tangential-flow filtration (TFF)

Features: Revolutionary purification platform automates, documents, and analyzes any TFF application needed in a GMP environment. The user-friendly interface is built on the familiar Windows XP operating system and .NET framework; administrative users have easy access to and control over all process parameters, users, permissions, and recipes. The system logs all program variables and automatically maintains optimal TFF conditions through continuous data acquisition and precision control loops.

Contact SciLog www.scilog.com

Sterilization

Product: No. 970 500 °F (∼260 °C) electrically heated, class 100 cleanroom oven

Applications: Sterilization, depyrogenation, curing, and drying

Features: The unit measures 33-in. wide × 42-in. deep × 66-in. tall and is heated by 30-kW Incoloysheathed tubular elements. A 2,400 cfm, threehorsepower recirculating blower provides horizontal airflow to the workload. Has 4-in. thick insulated walls throughout with aluminized steel exterior, and Type 304 2B-finish stainless steel interior with continuously backwelded seams, exterior finished with white epoxy paint, #4 brushed finish stainless steel door and control panel face.

Contact Grieve www.grievecorp.com

Cell Culture Monitoring

Product: GlucCell glucose monitoring system

Applications: Glucose concentration measurement in mammalian and insect cell culture

Features: Calibration-free device is a merger of glucose biosensor technology with microprocessor-based instrumentation. The glucose test strip requires a sample volume of less than 3 µL and provides a result in 15 seconds. The device accuracy is correlated at 99.5% with other biochemical analyzers on the market, and accuracy is not affected by the type of culture medium. Disposable test trips eliminate the risk of contaminating the device and the environment, making it especially suitable for biohazardous production (e.g., virus production).

Contact CESCO Bioengineering Co., Ltd. www. cescobio.com.tw

Biostability

Product: RNAstable

Applications: Preservation of RNA at room temperature

Features: The technology forms a thermostable barrier that securely “shrink wraps” RNA samples to protect them, addressing the degradation problem of working with RNA. To store the RNA, researchers simply can pipette samples into a tube or well filled with the product and allow it to dry. Sample recovery requires hydration with simple H₂O. RNA is preserved at room temperature for up to five months and has demonstrated an equivalent of three-and-a-half years of stability under accelerated aging conditions. RNA samples recovered following stabilization with the product can be directly used in qRT-PCR, bioanlyzer and microarray analysis, end-point PCR, gel analysis, cDNA analysis, and reverse transcription without inhibition or interference.

Contact Biomatrica www.biomatrica.com

Product Development

Service: Vetter development service

Applications: Early stages of product development or services for products already on the market

Features: The company offers expertise and advice in primary packaging development, process development, clinical manufacturing, pharmaceutical analysis, regulatory affairs services, and technology transfer to commercial

manufacturing. For primary packaging, the company will help with selection of the most suitable injection system. Pharmaceutical analysis services includes quality control of raw materials, packaging materials, bulk solutions, in-process materials, and the finished products. Regulatory services include document preparation for international regulatory approval and provision of regulatory services throughout the registration process.

Contact Vetter www.vetter-pharma.com

Chromatography

Product: ProSep Ultra Plus affinity chromatography media

Applications: Antibody purification

Features: This Protein A based affinity resin has the highest dynamic binding capacity and flow rate capability of any comparable resin on the market.Based on the proven technology of the ProSep media family, the newest addition can deliver the most costeffective solution to protein A affiinity MAb capture processing. Additionally, the rigid base matrix enables predictable scale-up and process flexibility.

Contact Millipore www.millipore.com

Bioprocess Analysis

Product: SIRE Bio laboratory systems

Applications: Cell cultivation and fermentation testing

Features: The systems provide accurate and rapid determination of D-Glucose levels for monitoring and control of cell culture and fermentation. Samples containing bioprocess media are complex because of microorganism activity, and the sample matrix varies during the process. Traditional methods (e.g., HPLC, enzymatic manual kits, glucose strips) are often timeconsuming and/or expensive because of instrument investments or are insufficient for certain types of samples or at low glucose concentrations. This automatic single-test analysis system offers your laboratory analysis times of less than five minutes, including reagent preparation.

Contact Chemel AB www.chemel.com

Scientific Networking

Service: BioMedExperts.com social networking site

Applications: Promote collaborative medical research and development

Features: This web site currently includes 1.4 million profiles and 12 million preestablished network connections from 120 countries. It is a collaborative effort between Dell and Codexis to help drive information sharing and discussion among biomedical and the life science research community.

Contact BioMedExperts.com www.biomedexperts.com

GMP Manufacturing

Service: Fast Trak training and education

Applications: Biopharmaceutical manufacturing operations

Features: Hands-on training courses are available for process development and manufacturing operations. Classes are limited to eight to 12 attendees with a high teacher-to-student ratio. Courses are offered in process development, monoclonal antibodies, membrane filtration, column packing, and UNICORN sy
stem control. Classes are designed for process developers, manufacturing scientists, staff scientists, engineers, plant operators, and support staff.

Contact GE Healthcare www.gehealthcare.com

Fermentation

Service: CellMaker Lite2 disposable fermentor rental

Applications: E. coli and P. pastoris protein production

Features: The single-use bioreactor incorporates a unique culture vessel geometry designed to provide cell cultures with gentle yet effective mixing and oxygenation, with k_La values equivalent to steel stirred systems. The system does not require mechanical means to mix or oxygenate, instead relying on the aeration process to mix the culture. A rental plan with monthly payments is helpful for those wishing to evaluate the technology before committing to final purchase.

Contact Cellexus Biosystems www.cellexusbiosystems.com

Spectrometry

Product: Air-cooled Peltier accessories

Applications: UV-Vis spectrometry

Features: These accessories deliver precise temperature control in a convenient and compact air-cooled design. They offer a low maintenance and efficient alternative to traditional liquid thermostatted devices for assays that require accurate and constant temperature control. The small, solid-state devices consist of semiconductor junction bonded to two plates to which a direct electrical current is applied and are widely used for temperature control. By using air instead of water, the systems provide scientists with greater efficiencies by eliminating the laborious procedure of monitoring recirculating water levels, adding antifreeze and antibacterial mixtures to a water cooling system.

Contact Thermo Scientific www.thermo.com/peltier

Fluid Connections

Product: Click-N-Seal connection fittings

Applications: Fluid connections in scientific equipment

Features:This device prevents overtightening to eliminate poor fluid

connections and leaky processing. Once the correct torque is reached, an operator can hear an audible “click” of the fitting, and is physically prevented from tightening beyond that point. The fitting can easily be unthreaded for reuse, and it ensures the correct torque through repeated tightening. The fittings produce a consistent fluid path and internal tubing diameter in any type of fluid line, eliminating leaks, dead volumes, and carryover problems.

Contact Diba www.dibaind.com

Batch Analysis

Product: DynaPro Titan plate reader

Applications: Automated, noninvasive dynamic light scattering for biomolecular characterization

Features: This instrument incorporates patented state-of-the-art technology to deliver superior performance and integrated data collection and analysis software, and it is designed for stable and accurate protein batch analysis. Alternative methods harm sample stability, but this system does not suck samples from the well plate, and thus does not perturb them. It eliminates risk while reducing operation time, and software can be customized to integrate with any industry-leading robotic liquid handling system. Protein samples can be analyzed in duplicate or triplicate to ensure the greatest possible accuracy.

Contact Wyatt Technology Corporation www.wyatt.com

Quality Control

Product: MVS multichannel verification system

Applications: Automated liquid handling quality control

Features: A rapid, easy-to-use system provides NIST-traceable accuracy and precision data documenting volume dispense performance of each channel of an automated liquid handler. New enhancements to the sytem facilitate inprocess quality control assessment and minimize manual intervention during volume verification protocols for time savings and added convenience. To further reduce equipment verification time, users can store each step of their liquid handler quality control protocols in the MVS system software for continual future access.

Contact Artel www.artel-usa.com

Single-Use Systems

Product: Single-use processing systems from AdvantaPure

Applications: Biopharmaceutical processing

Features: Consisting of silicone tubing, molded silicone components, and other processing related parts, the system offers cost reductions over stainless steel while increasing productivity. Well-known platinum-cured silicone products (tubing, hose, and molded silicone components) can be integrated with other process components such as bottles, bags, and valves for a finished, ready-to-use part.

Contact AdvantaPure www.advantapure.com

Protein Product Analysis

Product: M-110P Microfluidizer processor

Applications: Bench-top nanoemulsions and suspensions, liposomal encapsulation, and cell disruption

Features: Designed to operate reliably, quietly, and efficiently at 30,000-psi process pressure, the portable device requires a 20-amp, single-phase, “household” electrical outlet for incorporation into any laboratory setting. It uses a fixed-geometry diamond interaction chamber technology and ceramic plunger for easy production with few passes. The system allows flow rates between 110 and 155 mL/min depending on process pressure. All results from the device are guaranteed to be scalable to pilot and/or production volumes.

Contact Microfluidics www.microfluidicscorp.com