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UNICORN Control Chromatography System

Source: GE Healthcare Life Sciences

unicorn chromatography system
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UNICORN is the control system for real-time control of protein purification unit operations (column packing, chromatography and filtration) from laboratory bench, through development, to full-scale production. UNICORN is used world-wide in over a thousand laboratories and controls hundreds of process development and production systems.

UNICORN control system meets the needs of full-scale production with manufacturing systems, while maintaining the flexibility needed for method and process development with the range of systems in the ÄKTA family. This flexibility allows quick and simple transition from one stage of a project to the next. Clinical trial equipment can be turned into a final production installation overnight. Documentation and user interface remain consistent from one step to the next and re-investment and validation requirements are reduced to a minimum. UNICORN can also be adapted to control other liquid handling process units, or to connect to other control systems in a plant via the OPC interface.

Among the many features of UNICORN are easy method programming, powerful functions for method assessment, a dynamic display to keep you posted on process status, and the configurable user access profiles to keep your methods secure. In addition, UNICORN can simultaneously supervise up to four liquid handling units from a single work-station, independently or in a pre-programmed sequence. Full validation support for the control system software is available to help speed your product to market. The software consists of separate modules for method programming, system control and data evaluation.

Easy method programming
Most complex valving sequences are handled through valve macros. Programming can be done in time, volume or column volume base. Automatic scouting of important separation variables is easily performed. Conditional responses to specific monitor signals (UV, conductivity, pH, pressure and air) are established through simple WATCH commands.

Real-time process monitoring
As the chromatography run progresses, selected monitor signals are displayed numerically or as trend curves. The process picture with actual flow path and the continuously updated logbook can be displayed.

Real-time control
Up to four systems can be connected to one UNICORN workstation where individual controllers handle the realtime control of each system. Data evaluation or methods programming can be done while the systems are running.

Extensive data evaluation
All monitor data are stored in a Result File for storage and evaluation. Extensive data processing routines include curve smoothing, differentiation, normalization, baseline calculation, peak integration and height equivalent to a theoretical plate (HETP) calculations.

Batch documentation
UNICORN methods can be transferred between systems at different scales. Along with the chromatographic results of each run, the Result File also includes the programmed method, start protocols, notebooks and the logbook. These files are protected and cannot be manipulated. Processed data generated from an evaluation procedure are stored in the Result File, but separate from the original data.

Security
UNICORN provides a system for password authorization and access control. Operators log in by name and password. The user profile includes an access level that defines system functions available to each operator.

Scalability
Using UNICORN for method or process development on ÄKTA systems simplifies scale-up to BioProcess system. Personnel retraining is minimized and continuity exists in batch documentation and report generation.

Validation support
UNICORN is fully compliant with 21 CFR Part 11 and is extensively documented for validation purposes. A Validation Support File is available describing our software development model including routines and test models.

UNICORN DAQ 1.0
UNICORN DAQ 1.0 software provides data acquisition for the management and evaluation of results from cell cultures performed in WAVE Bioreactor systems. UNICORN DAQ software provides the following benefits:

  • Real time data acquisition allows you to monitor the run status of a connected WAVE Bioreactor 20/50 or 200 system
  • Simultaneous monitoring of up to four different instrument configurations enables efficient data acquisition
  • A common platform and user interface for all culture volumes simplifies scale up
  • Secure and unalterable result files

UNICORN DAQ software facilitates online data acquisition for the management and evaluation of results from cell cultures performed in WAVE Bioreactor systems, part of the ReadyToProcess platform. Up to four different WAVE Bioreactor systems can be simultaneously connected to a single PC or networked to the software providing a common platform for acquiring, monitoring, and storing result data. A dynamic graphical user interface informs the user about the real time status of the run being monitored while data are automatically saved to a local hard drive or server in a secure and unalterable result file for added security. A common platform and user interface for all culture volumes simplifies scale up.

Modular format for easier navigation
UNICORN DAQ software comprises three program modules that automatically open at logon. Data acquisition is set up and started in UNICORN Manager and monitored in the System Control module while result data are managed using the Evaluation module.

Validation with UNICORN software
UNICORN software has an installation wizard that checks the setup and the installation and functionality of the Flow Kit and sensors. A report is generated with completed installation procedures including instructions from the wizard, traceability to Flow Kit, process information, and results from the component test. The installation wizard also contains instructions and reports for column installation. UNICORN has undergone an independent audit and is designed as a control package in FDA 21 CFR part 11 and GMP compliant environments. The record system uses a document locking scheme and traceable audit log. For integration purposes, UNICORN communicates with control systems within the plant via OLE for Process Control (OPC). OPC supports application areas such as data access for real time values and security control to protect sensitive information.

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