GE Healthcare, a $17-billion unit of General Electric, employs 46,000 people worldwide and is headquartered in Chalfont, St. Giles, Buckinghamshire, U.K. GE Healthcare Life Sciences (www.gelifesciences.com), one of six main business units of GE Healthcare, has international headquarters in Uppsala, Sweden, and “focuses mainly on protein analysis and purification,” says Peter Ehrenheim, the division's president and CEO. The staff at the Swedish facility makes systems and equipment for the purification of biopharmaceuticals and produces technology for drug discovery, biopharmaceutical manufacturing, and cellular analysis.
In both research and design and the manufacturing of approved drugs, the desired proteins must be purified with chromatography and filtration methods. GE Healthcare Life Sciences provides chromatography systems, columns, and media that can be used throughout laboratory bioprocess development, pilot plant scale-up, and commercial manufacturing.
For research, process development, and pilot plant production, proteins are isolated and purified in the laboratory on small-scale systems. The AKTA™ platform of chromatography instruments, whose name derives from a Swedish word for pure, is a fully integrated protein purification system that delivers automated, high-throughput purification. More than 25,000 AKTA systems have been installed in laboratories worldwide. “This product is ideal for anyone who wants to purify a protein for research purposes, manufacture diagnostic kits, or do process development work,” says Ehrenheim.
AKTAxpress™ is useful to researchers who need large amounts of pure proteins to determine three-dimensional structure. The system can run unattended and gives excellent reproducibility, according to the company. The AKTApilot™ chromatography system is a benchtop process development and production system. Researchers use it for scale-up from the research laboratory stage to process optimization and production and to produce materials for clinical trials.
Membrane separations complement chromatography, and, in 2002, GE Healthcare acquired a Massachusetts company that specialized in cross-flow filtration. “That’s how we got into the area of membrane filtration,” reports Ehrenheim. This acquisition allows the company to offer filtration methods to separate substances in solution by passing them through semipermeable membranes under pressure in either hollow fiber or flat sheet formats.
“Our hollow fiber membranes are unique,” says Ehrenheim, and can purify highly contaminated solutions at high concentrations. Hollow fiber membrane cartridges and systems can purify monoclonal antibodies, plasma factors, recombinant proteins, and vaccines. “Some people claim that you can filter cream cheese through hollow fiber filters,” Ehrenheim adds. A key feature of hollow fiber cartridges is their ability to filter solutions containing mammalian cells without damaging the cells during the process.
Filtration membranes are supplied as Kvick™ cassettes, which consist of dense membrane matrixes arranged in flat sheets of varying sizes. Kvick disposable cassettes come in several configurations, and all are designed without internal spaces that could trap solutions. This feature insures a high recovery rate and high yields of the desired final product. The Kvick Lab system, a flexible lab-scale separation system, comes with five molecular weight cutoffs to fit a broad range of cross-flow applications.
The company’s UniFlux™ membranes were created specifically to securely manage bioprocess separations. They can be controlled automatically with special software, which monitors both membrane and chromatography systems. This gives better efficiency and lower costs compared to systems in which membrane separations and chromatography are managed separately.