Liquid Chromatography System For Scale-Up Biomanufacturing: ÄKTA

Source: Cytiva
Liquid Chromatography System For Scale-Up Biomanufacturing: ÄKTA

ÄKTA ready is a liquid chromatography system built for process scale-up and production for early clinical phases. The system can be used with ready-to-use disposable flow paths, eliminating the need for cleaning between products/batches. Two versions of ÄKTA ready are available: one version for only isocratic use and the other with gradient capability.

  • Simple exchange of the complete flow path eliminates the need for system cleaning including method development and validation.
  • Improved economy and productivity due to simpler procedures, reducing downtime between products/batches.
  • Risk for cross-contamination between products/batches is minimized.
  • Scalable processes using UNICORN control software.
  • Accompanied by extensive product documentation.

The ÄKTA ready system comprises an ÄKTA ready chromatography unit, UNICORN control software, and disposable ÄKTA ready flow paths including detection flow cells. Two versions of ÄKTA ready are available: one version for only isocratic use and the other with gradient capability. The system can be Installation and Operation Qualification (IQ/OQ) qualified by the customer or by a certified specialist. A UNICORN wizard guides the operator on how to install the flow path and performs an installation test prior to running the system.

Part of ReadyToProcess

Our ReadyToProcess platform consists of ready-to-use solutions for entire manufacturing processes. After a purification step has been completed using ÄKTA ready, the single-use flow paths (i.e., ÄKTA ready flow kits and gradient flow sections) are disposed. ReadyToProcess columns can be reused for several batches within the same purification campaign.

With ReadyToProcess, you can considerably speed up processes and save time due to fewer operations. There is no need to establish and validate cleaning procedures, and no complex setup. The flow paths can be changed quickly, with a downtime of less than 1 h. This saves time, capital investment, start-up costs, labor costs, and costs for consumables.

Robust and Hygienic Design

The ÄKTA ready system is resistant to chemical agents used in protein recovery, including buffer solutions for adsorption, elution and washing, and regeneration and cleaning solutions.

All material is of proven quality, and the flow paths are disposable. All wetted materials are fully biocompatible (USP class VI), and of animal-free origin or compliant with EMA/410/01. The materials used are traceable back to their production batches. The flow paths are produced under controlled conditions and packed in a clean room environment (class ISO 7) using validated protocols.

Regulatory Product Documentation and Services

Process safety is an integral part of the ÄKTA ready system and this includes the exchangeable flow paths. ÄKTA ready flow paths are supported with an extensive documentation package and support.