Products, Services, and Literature May 2008

Downstream Processing

Product: Cogent µScale tangential-flow filtration (TFF) system

Applications: Downstream process development and low-volume sample preparation

Features: The easy-to-use, semiautomated benchtop system has been designed to support TFF process development at the microscale using up to three Pellicon 3 88-cm² cassettes. With a low minimum working volume, the ability to operate at feed pressures up to 80 psig and very low pulsation, the system fully supports both scaling studies and low-volume ultrafiltration and diafiltration (UF/DF) work using the cassettes. It is ideal for purifying and concentrating MAbs, recombinant proteins, vaccines, gene therapy constructs, blood serum products, and other cell-derived components.

Contact Millipore www.millipore.com

Fluid Processing

Product: Standardized offering of M-7125 and M-7250 Microfluidizer high-shear fluid processors

Applications: Cell disruption and nanoemulsions and nanodispersions

Features: Six standardized configurations have been designed to cost-effectively meet the varying needs of the biopharmaceutical industry. Configurations begin with the standardized basic package, including a skid-mounted pharmaceutical-grade feed pump, a sanitary flush diaphragm pressure transducer with digital readout, and certified product contact surfaces. This ranges up to an advanced constant pressure system, with facilities for aseptic processing, data acquisition and recording, closed-loop-temperature-controlled product heat exchangers, and real-time product flow measurement.

Contact Microfluidics www.microfluidicscorp.com

Nutrient Media Preparation

Product: 30-L MediaClave

Applications: Sterilization of microbiological media

Features: A highly safe and economic system for sterilization of microbiological media, this instrument comes with a stirring mechanism that produces homogenous mixtures at 75 or 150 rpm. It can be converted to a compact bench-top autoclave and is particularly suitable for the individual and economical sterilization of media in small volumes. This instrument is ideal for autoclaving glassware, instruments and other laboratory material, with all the necessary safety devices of a modern autoclave, including support pressure compressor.

Contact Integra Biosciences www.integra-biosciences.com

Supply Chain

Service: Good manufacturing practices (GMP) audit solutions

Applications: Product safety and quality

Features: GMP audits from SGS allow customers and suppliers to ensure the quality, integrity, and safety of ingredients, packaging, and the entire supply chain through a combination of compliance monitoring, preinspection assessments, gap-auditing, and specialized training and consultancy services. With a global network of laboratories and experienced staff, SGS can respond to a wide range of customer needs — from large manufacturers in North America and Europe who need to ensure the quality of their inputs to smaller suppliers in Asia and Latin America who must prove that their production processes and quality meet global standards.

Contact SGS www.sgs.com/pharma-gmp

Fluid Management

Product: Single-use fluid management technology with exclusive integrated GammaTag gamma-stable radio frequency identification (RFID)tag

Applications: Tracking of bioprocess containers

Features: The integration of GammaTag provides total paperless traceability and facilitates quick retrieval of batch-related information through a gamma-stable medium. RFID technology enables users to both read and write all relevant product and process information directly on each component, providing for instantaneous recall. The tag also provides users with immediate access to a component’s original part number, lot number, date of manufacture, sterilization data, expiration date, and other critical item-level data normally contained in the product certificate of quality.

Contact Sartorius Stedim Biotech www.sartorius-stedim.com

At-Line Monitoring

Product: GRAVI-Chip system

Applications: Protein A–based assays

Features: This is a convenient microfluidics device for running bead-based ELISA and affinity assays in five to 10 minutes. The GRAVI system can handle samples and reagents from conventional plates or tubes, and it automatically pipettes these into a tilted linear microchannel array arranged in SBS compatible format. The system significantly decreases sample and reagent consumption and enables performance of multimenu immunoassays with simplified robotics and laboratory infrastructure. It was ranked among the top 10 finalists at the Association for Laboratory Automation 2008 show.

Contact DiagnoSwiss www.diagnoswiss.com

Fluid Movement

Product: Advantage Excel-Series S actuator (AXS)

Applications: Bioprocessing

Features: The actuator integrates unique design features into an integrated envelope for functionality. It includes a maintenance-free actuator with a modular compressor to make quick changeovers between elastomer and polytetrafluoroethylene diaphragms. Manufactured with a stainless-steel housing, the AXS is a cost-effective alternative for cleanrooms and other applications needing an actuator. The design also features easy access to bonnet fasteners, optional adjustable opening stops (AOS), and visual position indication. Additionally, the assembly can be rotated 360° in 90° increments to provide easy access to internal ports.

Contact ITT Corporation www.itt.com

Genetic Engineering

Product: CompactPrep Plasmid Mega and Giga kits

Application: Plasmid DNA isolation

Features: The kits offer greater convenience and faster extraction than other methods. Their purification capacity is up to 2.5 mg of plasmid DNA for the Mega kit and 10 mg for the Giga kit. Kits allow isolation in <50 minutes using a vacuum-driven protocol. Kits use small columns that enable elution of DNA in a very low buffer volume, resulting in DNA concentrations of up to 2.5 µg/µL. When a supplemental wash buffer is used, endotoxin levels are usually lower than 1 EU/µg DNA.

Contact Qiagen www.qiagen.com