When you’re ready for scale-up, GE Healthcare has high productivity chromatography media for cost-effective production of MAb therapeutics.
We also offer two different approaches to large-scale manufacturing: disposable solutions for fast and flexible manufacturing, or the latest breakthroughs in stainless steel processing equipment.
Disposable solutions save time and eliminate the effort you normally devote to tasks such as packing, cleaning and validation. Alternatively, choose stainless steel processing equipment where the latest breakthroughs boost the productivity of conventional biomanufacturing installations.
Significant time savings can be achieved in downstream processing when column packing, qualification, and sanitization are made redundant and disposable flow paths are used. ReadyToProcess columns are ready for immediate use with ÄKTA ready automated chromatography system for process scale-up and production of material for clinical trials.
ÄKTA ready chromatography system operates with quick-change, disposable flow paths that enable flexibility and speed in bioprocessing. This enables manufacturers running a large number of parallel projects gain the flexibility to easily switch between projects. ÄKTA ready has the design, functionality, and documentation to support its use in GLP and cGMP environments for Phase I-III in drug development and full-scale production.
ReadyToProcess columns are packed with BioProcess media, including MabSelect and Capto, and are available in four different sizes to facilitate scalability (1.0 l, 2.5 l, 10 l, and 20 l). They are also cost effective as they lower buffer consumption and reduce cleaning validation demands. Their robust construction and performance confers reliability and process security.
MabSelect SuRe chromatography media provides an efficient platform approach. It captures MAb from the feed, concentrates it, and removes bulk impurities and proteolytic enzymes. MabSelect SuRe LX develops this further to give even higher binding capacity at longer residence time and is optimized for quick and efficient processing of large volumes of high-titer bioreactor feeds. For the intermediate/polishing step, there are several suitable media based on different chromatographic techniques.
One alternative is to use a strong multimodal anion exchanger such as Capto adhere that makes it possible to design a
two-step process. Capto or Capto ImpRes media also provide fast and effective solutions when a third step is needed.
MAb Media Toolbox
MabSelect SuRe and MabSelect SuRe LX: Withstands rigorous yet cost-effective CIP/sanitization due to lower leakage, alkali-stabilized protein A ligand. Increases product safety and process robustness.
Capto adhere: A multimodal anion exchanger for fast, efficient and cost-effective purification of MAbs following a Protein A affinity step.
Our range of AxiChrom columns used together with ÄKTA design systems and related processing equipment provide a design flexibility that is lacking in traditional large-scale manufacturing. Features, such as Intelligent Packing, assure fast and reproducible packing results. Several previously time-consuming or labor-intensive tasks now take on an intuitive dimension.
ÄKTAprocess chromatography system can be used to scale up MAb purifications from ÄKTA avant, ÄKTApilot, and ÄKTA ready to large-scale manufacturing. Versatile configuration, plus UNICORN control, offers many system design possibilities. UNICORN also takes command of the verified, preprogrammed packing methods that ensure optimal packing of media in AxiChrom columns.
If a fully-customized system will better suit your needs for profitable, long-term production in highly-regulated environments, a GE Healthcare Customized BioProcess System (CBS) solution may be the answer. Working with you, we can design, manufacture, install and validate systems to your specific requirements.