GE Healthcare has launched Aktaready, a liquid chromatography system designed for process scale-up and production for Phase I-III drug development and full scale production to GLP and CGMP standards.
The company said that simplified system handling and reduced downtime between products and batches improves cost-efficiency and productivity by saving time and expenditure for start-up, labour and consumables.
Aktaready operates with ready-to-use, disposable flow paths, eliminating the risk of cross-contamination and the need for cleaning and validation of cleaning procedures.
It comprises the chromatography unit, Unicorn software, and a disposable Readytoprocess Flow Kit including sensors and detection flow cells.
Unicorn includes an installation wizard that provides instructions and reports for column installation and ensures correct functionality of the Flow Kit.
All Akta systems use the same software, which enables easy process scale-up and quick transfer to Aktaprocess for use in full CGMP production.
The Aktaready system is supported by regulatory product documentation and services, including validation documentation, product documentation with information about materials used, USP Class VI CFR 177 and AOF certificates and a Regulatory Support File (RSF).
Aktaready is part of GE Healthcare's portfolio of Readytoprocess solutions that help increase the efficiency in biopharmaceutical production.
Readytoprocess enables lean production schemes by eliminating waste activities in daily routines of upstream and downstream processing.
Products include the Wave Bioreactor and Wave Mixer with the disposable Cellbag, chromatography columns as well as normal flow capsules, and the Readymate disposable aseptic connectors.
The Readytoprocess portfolio provides flexibility, simplifies and speeds up bioprocessing and is designed for scalable and smooth operations from fermentation through to purification.
