The company's launch of Ficoll-Paque Premium offers the first sterile media for mononuclear cell preparation that is compliant with both the International Organization for Standardization (ISO) and the European Commission guide to good manufacturing practice (GMP).
Ficoll-Paque Premium is an upgrade of the currently available product, Ficoll-Paque Plus.
The new product, however, is manufactured in a strictly controlled environment for a higher product quality and safety, ensuring product sterility, low endotoxin levels, and reproducible performance.
"Compliance to GMP and quality standards is increasingly important to our customers using reagents such as Ficoll-Paque," said Nigel Darby, VP of research and development, protein separations at GE Healthcare.
"The new Ficoll-Paque Premium provides our customers with all the attributes of Ficoll-Paque Plus, but with the addition of stringent manufacturing process controls and adherence to quality-control systems to reduce risk," he said.
Ficoll-Paque Plus has been used for many years as a sterile density medium to isolate high yields of mononuclear cells from bone marrow, peripheral -and umbilical cord blood.
ISO and GMP compliance requires stringency in validation and documentation of manufacturing procedures, and adherence to strict quality systems.
GE Healthcare has also introduced a new flexible liquid chromatography system with a configurable design concept to provide maunfacturers with a tailored system.
The äKTAprocess offers manufacturers thousands of configuration possibilities so specific process demands can be met by choosing construction materials, flow rate ranges, valves, pumps and a variety of other options for fast and efficient purification in downstream processing.
"Today's biopharmaceutical process development and manufacture demands reliable delivery of protein composition during downstream processing," said Mats Grahn, VP of product management, Protein Separations, Uppsala, Sweden.
"äKTAprocess is designed to enable faster time to market by increasing the speed and efficiency of process development and manufacturing.Each system will be configured to the customer's specific needs, and should these needs change in the future, the modular design of äKTAprocess makes it possible to alter the configuration," he said.
äKTAprocess can be incorporated into low-pressure chromatography processesand is compatible with all chromatography columns used in the biopharmaceutical industry.
The systems are manufactured with materials that conform to USP class VI. The materials are fully traceable, and are tested and classified according to USP (88) Biological Reactivity Test.
GE Healthcare has also launched an advanced software option that enables remote access to the capabilities of the Advantage Workstation (AW) - one of the world's most widely used 3D visualization and analysis solutions for medical diagnostics.
The new software allows clinicians and physicians to apply AW functionality virtually anywhere, anytime via a PC or laptop computer.
Instead of spending their time getting to an AW to review and evaluate patient studies, clinicians will be able to interact with the images directly from their desktops or laptops.
"This should add up to higher productivity, faster diagnostic results, and happier physicians," said Dr. Thomas Suby-Long, body imaging specialist of diversified radiology of Colorado.
"Combine today's high-speed, wireless culture with our increasingly cost-constrained healthcare environment, and suddenly convenience and productivity become tremendously important," said Jennifer Dible, AW general manager for GE Healthcare.
AW RemoteAccess gives users a choice of two modes with which to access an AW.
In "remote review" mode, multiple users can simultaneously access one host AW, performing interactive MIP/MPR (maximum intensity project/multi-planar reformat) tasks on any exam available at that AW.
Clinicians may choose 3D review, multi-planar reformatting, real-time rotations, even ROI (region of interest), distance and angle measurements.
Alternatively, a remote user can tap this software's "virtual" AW mode, where they actually "drive" the host AW remotely, as if they were actually sitting in front of the AW.
AW helps improve diagnostic productivity by allowing clinicians to visualise, analyse and share multi-modality DICOM images, transforming data into decisions for patients in care areas like cardiology, oncology, vascular medicine and orthopedics.
Multiple users can be online to that AW at the same time, using it for Remote Review functions such as 3D image review.
Headquartered in the United Kingdom, GE Healthcare is a $15 billion (€12.4 billion) unit of General Electric Company. Worldwide, GE Healthcare employs more than 43,000 people in more than 100 countries.