ÄKTA™ pure Protein Chromatography Purification System
| Brand | Cytiva |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Product Origin | Imported |
| Model | ÄKTA™ pure |
| Flow Rate Range | Up to 25 mL/min (ÄKTA™ pure 25) / Up to 150 mL/min (ÄKTA™ pure 150) |
| Pressure Limit | Up to 20 MPa |
| Conductivity Range | 0.01–999.9 mS/cm |
| UV Detection Wavelengths | 280 nm, 254 nm (dual-channel fixed-wavelength) |
| Fraction Collection | Programmable, time- or peak-triggered |
| Software Platform | UNICORN™ 7.x |
| Compliance | Designed for GLP/GMP-aligned workflows |
Overview
The ÄKTA™ pure Protein Chromatography Purification System is a modular, benchtop-scale preparative liquid chromatography platform engineered for high-reproducibility purification of proteins, peptides, antibodies, nucleic acids, and other biomolecules across research, process development, and early-stage biomanufacturing environments. Built upon Cytiva’s decades-long heritage in chromatographic separation science, the system implements classical liquid chromatography principles—including ion exchange, size exclusion, hydrophobic interaction, affinity, and multimodal chromatography—within a robust, pressure-stable architecture capable of operating at up to 20 MPa. Its dual-flow configurations (ÄKTA™ pure 25 and ÄKTA™ pure 150) enable seamless scalability from analytical screening (µg–mg) to pilot-scale purification (mg–g), supporting method transfer between discovery and upstream/downstream development labs. The system integrates seamlessly with industry-standard chromatographic media (e.g., Sepharose®, Capto™, and SOURCE™ resins), and its hydraulic design minimizes dwell volume and gradient delay—critical for maintaining resolution during complex multi-step purifications.
Key Features
- Modular hardware architecture allowing configuration expansion: UV/Vis detectors, pH/conductivity monitors, fraction collectors, column switches, and auxiliary pumps can be added or reconfigured without system downtime.
- Benchtop footprint (W × D × H: 550 × 600 × 520 mm) optimized for placement in standard laboratory hoods, cold rooms (4–25 °C operational range), or controlled-environment cabinets.
- High-precision dual-wavelength UV detection (254 nm and 280 nm) with real-time absorbance ratio calculation (A260/A280) for rapid assessment of nucleic acid contamination in protein fractions.
- Integrated conductivity and pH monitoring with auto-calibration support and temperature compensation (±0.02 pH units, ±1% full scale).
- Pressure-controlled gradient formation using dual-piston high-pressure pumps, delivering linear, step, or multi-segment gradients with ≤0.5% RSD in flow accuracy across 0.01–150 mL/min range.
- Pre-validated method templates for >200 Cytiva laboratory-scale columns—including HiTrap™, Tricorn™, and XK™ series—with embedded column geometry, flow limits, and recommended buffer compatibility data.
Sample Compatibility & Compliance
The ÄKTA™ pure system accommodates aqueous and mild organic solvent-based mobile phases (up to 100% acetonitrile or isopropanol, compatible with most HPLC-grade solvents). It supports sample loading volumes from 10 µL to 500 mL per run and handles viscous or particulate-containing feedstocks via optional in-line filtration and degassing modules. All fluidic pathways are constructed from bio-inert PEEK, stainless steel (316L), and sapphire components to ensure minimal metal leaching and compatibility with low-pH elution buffers (e.g., 0.1 M glycine-HCl, pH 2.7) used in monoclonal antibody purification. The system meets ISO 9001-certified manufacturing standards and is designed to support compliance with ICH Q5, Q8, and Q9 guidelines. When equipped with UNICORN™ 7.4+ and appropriate server infrastructure, it fulfills FDA 21 CFR Part 11 requirements—including electronic signatures, role-based access control, and immutable audit trails—for regulated environments operating under GLP or GMP frameworks.
Software & Data Management
UNICORN™ software serves as the unified control, method development, and data analysis environment. It provides drag-and-drop method building, real-time overlay of multiple detector signals (UV, conductivity, pH, pressure), and automated peak integration using baseline correction algorithms compliant with USP . Raw chromatograms and metadata (including instrument logs, user actions, and environmental sensor readings) are stored in vendor-neutral .chm binary format, exportable to CSV, PDF, or XML for LIMS integration. Version-controlled method libraries support collaborative protocol sharing across sites, while built-in reporting tools generate IQ/OQ-ready documentation packages. Optional UNICORN Connect enables remote monitoring via secure HTTPS interface and scheduled data backup to network drives or cloud storage endpoints compliant with GDPR and HIPAA data handling policies.
Applications
- Purification of recombinant proteins expressed in E. coli, yeast, insect, or mammalian cell systems—including His-tagged, GST-fused, and native proteins.
- Antibody fragment isolation (Fab, scFv, nanobodies) using Protein A, Protein L, or mixed-mode resins.
- Removal of endotoxins, host-cell proteins (HCP), DNA, and aggregates during downstream processing.
- Method scouting and optimization for orthogonal chromatography steps (e.g., capture → intermediate purification → polishing).
- Stability-indicating assays for forced degradation studies (e.g., oxidation, deamidation) monitored via SEC or IEX profiling.
- Process characterization studies supporting Quality by Design (QbD) initiatives and regulatory submissions.
FAQ
What is the maximum operating pressure of the ÄKTA™ pure system?
The system is rated for continuous operation up to 20 MPa (2900 psi), enabling use with high-resolution monolithic and rigid-bead chromatography media.
Can UNICORN™ software be validated for use in GMP environments?
Yes—UNICORN™ 7.4 and later versions include configurable 21 CFR Part 11 modules (audit trail, electronic signatures, user authentication) and are supported by Cytiva’s validation documentation package (IQ/OQ/PQ protocols, risk assessments, and change control records).
Is method transfer possible between ÄKTA™ pure and larger-scale ÄKTA™ systems?
Absolutely—the system shares identical gradient generation logic, detector calibration standards, and UNICORN™ method syntax with ÄKTA™ avant, ÄKTA™ pilot, and ÄKTA™ process platforms, minimizing scale-up uncertainty.
Does the system support automated cleaning-in-place (CIP) routines?
Yes—predefined CIP methods (e.g., NaOH sanitization, ethanol flush) can be scheduled and executed with full parameter logging and alarm thresholds for conductivity, pressure, and flow deviation.
How is system performance verified after installation?
Cytiva-certified field service engineers perform IQ/OQ verification including pump accuracy, gradient precision, UV linearity (NIST-traceable holmium oxide filter), and detector noise/drift tests—all documented in a formal commissioning report.
