GE Healthcare. AxiChrom columns. Simple operation Superior performance

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1 GE Healthcare AxiChrom columns Simple operation Superior performance

2 Simple operation Superior performance The AxiChrom column platform is a revolutionary concept that simplifies column handling at all scales from process development to full-scale production. Developed from a long history of experience in column packing, the AxiChrom platform displays superior performance. Through its three key features - Intelligent Packing, intuitive handling, and predictable scale-up - AxiChrom columns introduce leanenabling practices that make process chromatography easier, safer, and more efficient. Intelligent Packing: preprogrammed, verified packing methods save time and ensure accurate and reproducible packing results. Built-in experience reduces dependence on the operator, and facilitates faster product changeover. Intuitive handling: columns are simple to operate and service. Pivot or swing-out column tubes are safer and easier to handle. The AxiChrom Master and UNICORN TM wizard guide users through key process steps to save time in method creation, set-up, and maintenance. Predictable scale-up: straightforward scale-up and techtransfer thanks to a liquid distribution system designed using analytical and computational fluid dynamic (CFD) modeling tools. Sanitizable column design that supports cleaning validation while full technical and regulatory support enables fast, trouble-free start-up.

3 Intelligent Preprogrammed packing methods save time Preprogrammed, verified methods for BioProcess Media not only speed up packing, but also make packing more operator independent. Repacking can be avoided and changing to different media and creating new methods is quick and simple. With smaller AxiChrom columns, operators create the packing method by entering packing variables in a UNICORN Intelligent Packing wizard on ÄKTAexplorer or ÄKTApilot systems. With larger AxiChrom columns, packing is guided and controlled by the interactive userinterface on the AxiChrom Master. bed height on the unit s touch-screen, or in the UNICORN method creation wizard. As packing is operator-independent, reproducibility is increased. Packing thus becomes a less critical element at all scales, and because repacking is avoided, production schedules can be kept on track. Faster product change-over The help and guidance built into the column, combined with its ease of use, reduces unproductive processing time from production schedules and thus promotes faster product or process change-over. Accurate and reproducible packing results Axial compression packing technology together with preprogrammed packing methods ensure that beds are always packed with optimal and reproducible compression. Operators only need to select the BioProcess medium to pack and then enter the slurry concentration and target

4 Intuitive Simple to operate and service Clear, interactive instructions make AxiChrom columns easy to prime, operate, and service, facilitating the development and implementation of SOPs. The novel design allows easy access to all relevant parts; disassembly, exchanging wetted parts, and reassembly can be done in less than one hour for larger columns. Guidance through key process steps Step-by-step instructions from the AxiChrom Master guide users through key steps of priming, packing, unpacking and maintenance. Checklists in the AxiChrom Master or a summary page in the UNICORN method wizard reduce the risk of errors and help save time, as previous experience or extensive training is not necessary. Safer operation with swing-out and pivot designs Even the largest AxiChrom columns can be handled safely by a single operator. Their swing-out design removes the need for hoists and reduces required production floor space. Transport from the production hall to areas for service and maintenance is unnecessary as this can be done in situ. For the small columns, the pivot stand design avoids the need for lifting and promotes safer operation with easy access to parts.

5 Predictable Easy tech-transfer and scale-up A distribution system designed and developed using analytical methods and modern CFD-modeling tools ensures reproducible and predictable results over the entire range of scales. Predictable performance facilitates scale-up and scale-down as well as techtransfer to different locations. Documentation to facilitate fast start-up Comprehensive documentation for all column sizes includes IQ/OQ documents and traceability for key column materials. These and other regulatory support measures speed up the planning and implementation of cgmp production. Design supports cleaning validation AxiChrom columns meet the high standards of sanitary design required for cleaning validation in cgmp production. Documented microbiological challenge tests demonstrate effective cleaning with sodium hydroxide and reduction of endotoxin levels to concentrations below those recommended by regulatory authorities.

6 Integrated services and support GE Healthcare can support you in every aspect of bioprocessing with practical help, proven products, and dedicated service. BioProcess Media Media like Capto and MabSelect are specifically designed to meet the demands of today s industrial biomanufacturing. BioProcess Media are produced according to validated methods and tested under strict quality control to fulfill key process performance specifications. ÄKTAdesign systems The ÄKTAdesign platform offers a range of purification systems from the lab-bench to full-scale production, all controlled by UNICORN software, which allows for easy transfer and scale-up of methods. Filtration products Our filtration portfolio includes products for cross flow and normal flow filtration applications. ÄKTAcrossflow TM and UniFlux TM systems, together with a range of membrane devices, provide integrated applications at every scale, from lab-bench to full-scale production. ReadyToProcess products Disposable WAVE Bioreactor technology and ReadyToProcess TM single-use columns, filters, and connectors offer faster and simpler bioprocess operations. Fast Trak Biopharma Services Fast Trak Biopharma Services provide a range of courses and process development consulting. Practical support and advice from Fast Trak can help you plan, implement and document upstream and downstream processes from startup to routine production, as well as train your personnel. Validation performance Executing Installation and Operational Qualification (IQ/OQ) and Change Control Protocols (CCP) requires knowledge of both the techniques and regulatory requirements involved. Our specially-trained and certified engineers perform onsite IQ/OQs and CCPs in accordance with cgmp, as well as providing on-site training for your personnel. Life Science Performance Solutions A range of services including Lean, Six Sigma, and Change Management programs help improve overall economics and shorten time from lab development to full-scale production. Security of supply Our large production capacity, clear ordering and delivery routines, and contracts for Media Safety Stock assure secure supplies of critical BioProcess Media. For systems and columns there are Spare Parts Locker and other service contracts to secure maximum processing uptime.

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8 GE, imagination at work, and GE monogram are trademarks of General Electric Company. ÄKTAcrossflow, ÄKTAdesign, ÄKTAexplorer, ÄKTApilot, AxiChrom, BioProcess, Capto, Drop Design, MabSelect, ReadyToProcess, UNICORN, UniFlux, and WAVE Bioreactor are trademarks of GE Healthcare companies. All third party trademarks are the property of their respective owners. 2008General Electric Company All rights reserved. First published Sept All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. A copy of these terms and conditions is available on request. Contact your local GE Healthcare representative for the most current information. GE Healthcare UK Limited Amersham Place Little Chalfont Buckinghamshire, HP7 9NA UK GE Healthcare Europe, GmbH Munzinger Strasse 5 D Freiburg Germany GE Healthcare Bio-Sciences Corp. 800 Centennial Avenue, P.O. Box 1327 Piscataway, NJ USA GE Healthcare Bio-Sciences KK Sanken Bldg., , Hyakunincho Shinjuku-ku, Tokyo Japan For contact information for your local office, please visit: GE Healthcare Bio-Sciences AB Björkgatan Uppsala Sweden AA 09/2008