High-Throughput Osmometry
Product: Advanced 20G osmometer
Applications: Cell culture process development and optimization
Features: New approaches to accelerate cell culture process development and optimization require higher sample throughput for osmolality testing. The Advanced 20G high-throughput osmometer was developed by combining state-of-the-art osmometry technology and robotics within a parallel sample processing scheme. Samples can be analyzed in 96-well format within 35 minutes, with the same accuracy as provided by stand-alone osmometers. This system has been applied to support osmolality testing in several demanding cell culture process development schemes in the biopharmaceutical industry.
Contact Advanced Instruments Inc.www.aicompanies.com
Disposable Containment
Product: FluoroFlex biocontainers
Applications: Biologic process solutions and active product ingredients
Features: Meissner’s polyvinylidene fluoride (PVDF)–based FluoroFlex biocontainers are made of a multilayer coextruded film that is extruded, manufactured into biocontainers, and packaged in ISO Class 7 cleanrooms. It is free of additives for an extremely low leachable–extractable profile. Thermal stability, chemical resistance, and robustness exceed those of polyolefin-based containers. An EVOH gas barrier helps mitigate the risk of degradation for process solutions and products inside. Elastomeric thermoplastic strength layers in the certified animal-component–free (ACF) film structure make it strong and flexible.
Contact Meissner Filtration Products, Inc. www.meissner.com
Media Transfer
Product: Cap2v8 sterile media bottles
Applications: Cell culture, laboratory research, pilot and process R&D, vaccine production, aseptic sampling, and other sterile transfer applications
Features: SaniSure Cap2v8 sterile media bottles use a one-piece molded cap design with no adhesives for 60-, 125-,250-, and 500-mL; 1- and 2-L; and other custom-sized one-piece bottle–closure systems. Unitized construction provides a closed system and an aseptic seal for high-purity biologicals. Meeting UPS Class VI requirements, these bottles are lot-traceable and certified sterile. Custom options include tubing, filters, fittings and end connections, sterile connectors, and other bottle variations.
Contact SaniSure, Inc.www.sanisure.com
Expedited Development
Service: Light Path product development service
Applications: Outsourced biologics
Features: Lonza’s Light Path service is streamlined to provide process development and custom (mg to kg quantities of) material supply for discovery to early clinical development. The minimial scope is tailored to meet immediate development goals by leveraging the company’s optimized platforms for improved turn-around times and lowered costs. This service is available for both mammalian and microbial cell culture applications from all five of Lonza’s biological development sites in Singapore, Switzerland, the United Kingdom, and the United States.
Contact Lonza Group Ltd.www.lonza.com
Membrane Chromatography
Product: Sartobind STIC membranes
Applications: Salt-tolerant interaction chromatography (STIC)
Features: Sartobind STIC membrane adsorbers bind negatively charged impurities such as DNA, host-cell proteins, endotoxins, and viruses at much higher salt concentrations than do conventional Q matrices. These STIC membranes eliminate the need for feed stream dilution before flow-through polishing of monoclonal antibodies and other recombinant proteins. These disposable, ready-to-use products reduce (cleaning) validation cost, buffer consumption, and equipment footprint. The membrane family scales linearly within the Sartobind SingleSep formats, from Sartobind nano 1-mL (36-cm2) up to larger capsules.
Contact Sartorius Stedim Biotechwww.sartorius-stedim.com
Antibody Enhancement
Service: GlymaxX technology
Applications: Enhancing antibody-dependent cell-mediated cytotoxicity (ADCC) activity
Features: Boehringer Ingelheim has licensed ProGioGen’s GlymaxX technology to integrate into its high-expression BI-HEX expression system based on Chinese hamster ovary (CHO) cells. This will help the company make afucosylated proteins as part of its contract service offerings. The technology can also be applied to existing antibody-producing cell lines without altering their productivity. ADCC activity is important to selective killing of target cells. ProBioGen’s technology prevents addition of fucose to N-linked antibody carbohydrates to enhance this activity.
Contact Boehringer Ingelheim GmbHwww.biopharma-cmo.com
Stem Cell Culture
Product: CompacT SC culture system
Applications: Automated T75 and T175 flask cell culture of stem cells
Features: For parallel, aseptic culture of multiple stem-cell lines, the CompacT SC system includes automated cell imaging and analysis to allow programming and monitoring of cell morphology and growth curves. The system can respond to preprogrammed changes by automatically passaging cells and adding new media, reagents, or vectors. Options include low-volume reagent dispensing, incubator oxygen control, and a module for automating plate-based cultures.
Contact TAP Biosystemswww.tapbiosystems.com
Protein Charge Analysis
Product: Möbius mobility instrument
Applications: Electrophoretic measurement of protein net charge
Features: Wyatt’s Möbius system’s optical design boosts the sensitivity of mobility measurements. Measuring protein charge has been challenging for phase-analysis light scattering (PALS) instruments that provide measurements only at high concentrations and high voltages — often with undesirable interactions between proteins and capillary walls. Through massive parallelism of light-scattering detection, the measurable molecular size range is extended below 2 nm, with measurement times
Contact Wyatt Technology Corporationwww.wyatt.com
Production Development
Product: DASbox modular miniature bioreactor system
Applications: Bioproduction process development (e.g., clone and cell line screening, media optimization)
Features: In a minimum footprint, the DASbox system is a fourfold modular system with 60- to 250-mL working volumes. Modules can be linked up for 24 or more miniature bioreactors (3-in. each) operating in parallel. A 24-fold system takes up ∼1.8 m of bench space. The system includes temperature and agitation control, pH and DO monitoring, and multiple pump and gas-mixing modules, as well as integrated storage slots for unused bioreactor components. DASware software supports QbD information management, integration of third-party analyzers, and DoE tools with remote-access capability.
Contact DASGIP AGwww.dasgip.com
Cell Banking
Product: CoolCell containers
Applications: Alcohol-free cell freezing
Features: BioCision’s CoolCell containers perform highly reproducible –1°C/min. freeze runs. No alcohol is required to control the freeze rate because the patent-pending design and materials ensure precise and uniform heat removal from 1-mL or 2-mL cryovials. An insulated design ensures constant and consistent cooling to all vials throughout freezing. No alcohol also means no ongoing cost, waste, or maintenance. The containers are unbreakable, open easily, are not cold to the touch when frozen, and can be used for another freeze run after only a five-minute wait. Each accommodates a dozen vials, and they come in three colors for color-coded batches.
Contact BioCisionwww.biocision.com
CHO Cell Line
Product: CHOZN cells
Applications: Bioproduction
Features: SAFC’s zinc finger nuclease (ZFN)–modified Chinese hamster ovary (CHO) cell lines are designed for use in production of monoclonal antibodies and other therapeutic proteins. These robust, regulatory-friendly cell lines are offered with full traceability. They offer high growth and productivity in suspension culture and chemically defined media with feed responsiveness, and good scalability. The CHOZN DHFR–/– line, for example, was developed through CompoZr ZFN-mediated gene editing of the dihydrofolate reductase (dhfr) locus in a robust, extensively characterized, and fully documented CHO-K1 host with which process development scientists can use any common dhfr expression technology.
Contact SAFCwww.safclive.com
An App for Temperature
Product: LOG-IC NFC app
Applications: Real-time temperature monitoring by smartphone
Features: ATI’s LOG-IC NFC smartphone app enables users to access the company’s data logger to scan, review, and communicate real-time temperature monitoring data. Based on the Android operating system, the app functions on any NFC-capable smartphone. All existing LOG-IC data logger capabilities are available through the app. Users can generate a range of reports, charts, and graphs; shara data; and export to other applications. General market availability is scheduled for January 2012 after a volunteer pilot program.
Contact American Thermal Instrumentswww.americanthermal.com