GE Healthcare - Bioprocess Solutions

GE Healthcare's overriding 'Healthymagination' program aims to improve quality, decrease cost and increase access to better healthcare around the world. Within the bioprocessing space, GE Healthcare provides products and expertise for developers and manufacturers of biotherapeutics to enable efficient, flexible and cost-effective approaches to characterization, expression and purification of biomolecules. The company offers tools and support to take recombinant proteins, monoclonal antibodies (MAbs), plasma proteins, oligonucleotides and vaccines from research, through process development, to full-scale manufacturing.

Bioprocessing, chromatography and filtration systems

GE Healthcare's portfolio encompasses both upstream and downstream processing. Key innovations include the ReadyToProcess™ platform, PreDictor™ 96-well plates for chromatography method development, modern BioProcess™ media, including MabSelect™ and Capto™ resins, for all phases of purification, ÄKTA™ systems for all scales of chromatography and filtration, and AxiChrom™ columns. The company also offers a full range of training courses and services covering these areas.

GE Healthcare's products enable improvements in process efficiency through optimized performance, advanced automation, simplified logistics, and removal of unnecessary procedures. These solutions allow agile manufacturing with shortened development times and excellent facility utilization. The company offers complete start-to-finish solutions in a range of areas such as monoclonal antibodies, plasma proteins, oligonucleotides and vaccines, and is continuously developing its range of products and services.

Ready-to-use products for bioprocessing

Biopharmaceutical development and manufacturing demands scalable processes that can be quickly developed and smoothly transferred to production. Ready-to-use technologies play a crucial role in providing the flexibility to support multi-product facilities. They deliver process time savings by removing steps such as cleaning, cleaning-validation, filter pre-washing and column packing, allowing faster start-up and easier changeover between products.

GE Healthcare's range of ready-to-use solutions encompasses tools for all operations in a process, from cell culture, through filtration to chromatography:

• Cell culture systems (WAVE Bioreactor™ and Cellbag™)
• Pre-packed and pre-sanitized chromatography columns (RTP columns)
• Chromatography systems (ÄKTA ready)
• Hollow fibre filtration cartridges and normal flow capsule filters (hollow fibre and ULTA)
• Disposable genderless connectors (ReadyMate™)
• Bags and tubing assemblies (ReadyCircuit™)
• Mobile processing station (ReadyKart)

Typical applications of ReadyToProcess products include:

• CGMP production for clinical trials
• Cell culture from cell bank through seed train to 500l production
• Aseptic cell processing
• Aseptic clarification and purification of vaccines, monoclonal antibodies and recombinant proteins
• Applications where terminal sterilization is not feasible
• Applications where containment is extremely important
• Fast-track development and manufacturing

96-well plates for chromatography method development

Time-to-clinic and time-to-market are two key factors in successful biopharmaceutical development. High-throughput process development (HTPD) shortens development time, while increasing the amount of information available for quality by design (QbD) approaches. Evaluation of chromatographic conditions can be performed in a high-throughput manner using GE Healthcare's PreDictor 96-well plates with Assist™ software. A wide range of experimental conditions can be evaluated simultaneously, allowing characterization of the design space and helping to define the process parameters that need to be monitored and controlled.

Chromatography system

The latest ÄKTA avant chromatography system with UNICORN™ control is designed for fast, scalable protein separations and has integrated design of experiment (DoE) functionality. The advanced configuration, flow and pressure capabilities of ÄKTA avant enable the use of modern, high-flow bioprocess chromatography media, shortening separation times and providing significant cost savings.

PreDictor plates and ÄKTA avant are the ideal combination for a modern process development laboratory.

Chromatography columns

GE Healthcare's AxiChrom columns have been designed to support lean column operation and maintenance. Through intelligent packing, intuitive handling and predictable scale-up, AxiChrom makes process chromatography easier, more reliable and more efficient. The columns have a novel design with a pivot or swing-out column tube that provides easy access for maintenance. AxiChrom columns are available with a range of lengths and with diameters from 50mm to 1m, covering process development, pilot scale and full-scale production.