Downstream Bioprocessing with ReadyToProcess
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. By freeing up time, manufacturers running a large number of parallel projects gain the flexibility to easily switch between projects. The ability to work in a regulated environment, efficiently and with manufacturing agility, is crucial for multiproduct facilities.
Disposable flow paths have several benefits. The flow path can be changed quickly, with a downtime of less than one hour. Disposable flow paths also eliminate the risk of cross-contamination by removing the need for cleaning between products/batches. Process economy is also improved since the kits are simple to change and require no development or cleaning validation.
The flow paths are available as Low Flow Kits for columns less than 20 cm in diameter and High Flow Kits for columns typically over 20 cm in diameter. 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. The ÄKTA ready system is controlled by UNICORN software, with a setup wizard that automatically checks the installation of new flow kits. All systems come with traceability documentation.
ReadyToProcess chromatography columns make column packing, column qualification, and sanitization redundant to achieve significant time savings in downstream processing. RTP columns are closed units and their design allows easy disposal after completed production. Plug and play columns reduce the risk of cross-contamination and ensure quick project changeover between applications.
The 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.
The columns can be used for the chromatographic separation of various compounds such as proteins, endotoxins, DNA, plasmids, vaccines, and viruses. ReadyToProcess columns are designed for purification of biopharmaceuticals for Phase I and II clinical studies. Depending on the scale, they can also be used for full-scale manufacturing as well as for preclinical studies.