Products, Services, and Literature April 2008

Process Monitoring

Product: SciLog conductivity, pressure, and temperature (pictured) sensors

Applications: In-line single-use purification monitoring

Features: Sensors come with embedded memory with stored IDs, serial numbers, lot numbers, calibration, and any calibration offsets. Products are cleanable with NaOH or sterilizable by autoclaving, ethylene oxide, or gamma irradiation. Sensors and monitors document parameter changes during processing and send them to a printer, programmable logic controller (PLC), or to a spreadsheet on a personal computer. They come in a variety of sizes and configurations, patents pending.

Contact SciLog, Inc. www.scilog.com

Cell Culture

Product: 19.5-L and 40-L sterilizable-in-place benchtop or mobile bioreactor

Applications: Pilot- and production-scale cell culture

Features: This modular system is designed to provide flexibility to meet changing process requirements, at any time, pre- or postdelivery. It includes options for gas flow, impellers, probes, spray balls, and validation operation, all of which enable customization. The system controls up to 32 loops from a touchscreen interface, with multiple analog inputs and outputs provided for connection of up to 14 external devices. A built-in load cell measures vessel volume for precise additions and harvesting, and 24 vessel penetrations provide flexibility.

Contact New Brunswick Scientific www.nbsc.com/bi6.htm

Cell Culture Production

Product: Regocel supplements

Applications: Mammalian cell culture performance and control

Features: These supplements were developed by bioprocess engineers to enhance protein productivity on average by 32%. They maintain excellent cell viability and accelerate process development and increase overall manufacturing efficiencies with reduced cost. The chemically defined supplement components have small-molecular weights (almost all <1,000 Da), and they are protein-, peptide-, and animal-derived–component free. Although the supplements are nonnutritive, they are compatible with nutritive feeds and all cell culture media.

Contact Girus Life Sciences www.girusinc.com

Fluid Movement

Product: APSPG peristaltic pump tubing

Applications: Peristaltic fluid movement

Features: This pump-grade, platinum-cured silicone tubing is USP Class VI approved, assuring users of its purity in critical applications. The extremely flexible product is specially formulated to withstand repeated compression and release for consistent, dependable performance. The tubing has excellent rebound and snaps back into its original form during pump use, resulting in steady fluid flow rates because of the tubing’s unchanging interior shape. The tubing also has smooth surfaces that resist bacteria build-up, low-volatile, platinum-cured silicone that meets FDA 21 CFR 177.2600, and operating temperature range of −73.3 °C to 204.4 °C and is sterilizable and autoclavable.

Contact AdvantaPure www.advantapure.com/apspg-peristaltic-pump-tubing.htm

Drug Delivery

Product: rP-nano technology

Applications: Highly targeted drug delivery

Features: The jointly owned technology uses the natural binding properties of recombinant protein nanoparticles to enhance drug and gene bioavailability. The technology can generate precisely sized nanoparticles within the range of 10–120 nm and can be optimized for enhanced permeability and retention effect. The nanoparticles produced through this process retain the natural binding properties of the recombinant proteins from which they are made. They bind to specific cell types to enable more targeted drug delivery with improved bioavailability.

Contact Novozymes www.novozymes.com

Anticounterfeiting Technology

Product: V-OVS NS needle shield for glass-barrel syringes

Applications: Prefilled syringes

Features: Patented tamper-evident closure for increased product integrity. The syringe is activated by separating its cap from the ring, in the same way as with conventional, standard needle-shields. A projecting squeezing points on the cap provide a firm grip for the fingers while the arrow on the closure indicates the direction for removing the cap. Ready-to-use closure protects the sterilization processes in the area of the needle while providing an aseptic seal for the filled system. Processing of the needle shield is possible on existing aseptic production equipment without the need for major modifications, keeping process flows unchanged.

Contact Vetter Pharma-Fertigung GmbH & Co. www.vetter-pharma.com

Laboratory Water Protection

Product: AquaTec water preservation cell

Applications: Prevention of waterborne contamination in CO₂ incubators and water baths

Features: Designed to provide worry-free sample incubation and cell culture, this product provides up to six months of protection from more than 600 types of bacteria, viruses, molds, and fungi. It enables the prevention of microbes from water without the use of harsh chemicals, making it safe to handle and requiring no special disposal protocols. The product works across a broad range of biological research environments. Each cell comes with optional suction cups for placement and fixation in a water bath or incubator reservoir and a peel-off reminder calendar that indicates when replacement is recommended.

Contact Thermo Scientific www.thermo.com/aquatec

Downstream Processing

Product: Protec RM filter

Applications: For the clarification, prefiltration, and bioburden reduction in biological liquids, vaccines, protein solutions, media and feeds, and cell removal from fermentation broths, precolumn chromatography, and biopharmaceuticals

Features: These filters are available in an expanded choice of absolute ratings 0.2 µm, 0.3 µm, and 0.5 µm. The design combines an outer layer of borosilicate glass microfiber media with an inner layer of proprietary hydrophilic PVDF membrane. It effectively protects downstream membrane filters and equipment. The filters consistently provide submicron contaminant removal, high dirt-holding capacity, and high flow rates while removing colloids, aggregated and nonproduct proteins, lipids, and other particles.

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

Fill and Finish

Service: GMP aseptic fill–finish and lyophilization service

Applications: Contract GMP fill and finish

Features: Brochure outlines the GMP aseptic fill and finish capabilities of Inotech Biotechnologies (Basel, Switzerland). The company offers filling capacity of up to 6,000 vials per hour (Format 2R). It offers development and optimization of lyophilization ccles, development of aseptic filling processes, procurement and release testing of raw materials and excipients, formulation including mixing validation, sterile filtration, and manual or automated filling of various types of containers. The company also offers visual inspection, labeling and packaging, analytical testing, process validation, and QP release.

Contact INOTECH Biotechnologies Ltd. www.inotech.ch

Intellectual Property

Literature: Online IP Handbook of Best Practices

Applications: Intellectual property (IP) management

Features: Prepared by and for policy-makers, leaders of public sector research establishments, technology transfer professionals, licensing executives, and scientists, this online resource offers up-to-date information and strategies for using the power of both IP and the public domain. Emphasis is placed on advancing innovation in health and agriculture, though many of the principles outlined here are broadly applicable across technology fields. The handbook includes 153 chapters on a full range of IP topics and more than 50 case studies composed by over 200 authors from north, south, east, and west.

Contact Centre for the Management of Intellectual Property in Health Research and Development, Oxford, UK www.iphandbook.org