Cytiva ÄKTA pure™ T Chromatography System
| Brand | Cytiva |
|---|---|
| Origin | Sweden |
| Model | ÄKTA pure™ T Chromatography System |
| Purification Principle | Gel Filtration Chromatography (GFC) |
| Gradient Type | Linear Gradient |
| Detectors | Dual-wavelength UV monitor (260 & 280 nm), Conductivity monitor, pH monitor |
| Flow Rate Range | ÄKTA pure™ 25T: 0.001–25 mL/min (up to 50 mL/min in column packing mode) |
| ÄKTA pure™ 150T | 0.01–150 mL/min (up to 300 mL/min in column packing mode) |
| Flow Accuracy | ÄKTA pure™ 25T: ±1.2% accuracy, RSD <0.5% (0.25–25 mL/min, <3 MPa, 0.8–2 cP) |
| ÄKTA pure™ 150T | ±1.5% accuracy, RSD <0.5% (1.0–150 mL/min, <3 MPa, 0.8–2 cP) |
| Pressure Range | ÄKTA pure™ 25T: 0–20 MPa |
| ÄKTA pure™ 150T | 0–5 MPa |
| Conductivity Range | 0.01–999.99 mS/cm |
| pH Measurement | 0–14 pH units, ±0.1 pH accuracy (pH 2–12) |
| Solvent Compatibility | Compatible with ≥1 mol/L NaOH and ≥2 mol/L NaCl for >3 hours of in-place cleaning per day |
Overview
The Cytiva ÄKTA pure™ T Chromatography System is a modular, high-performance liquid chromatography platform engineered for reproducible, scalable purification of biomolecules—including proteins, peptides, antibodies, and nucleic acids—across research, process development, and early-stage GMP environments. Based on Cytiva’s proven ÄKTA architecture and refined over five decades of protein science expertise, the system implements low-pressure, high-precision gradient elution chromatography using pump-driven solvent delivery, valve-switched fraction collection, and real-time multi-parameter detection. Its core operational principle relies on differential molecular interaction with stationary phases (e.g., size exclusion, ion exchange, affinity, hydrophobic interaction, or reversed-phase media), enabling separation based on size, charge, affinity, or hydrophobicity. The “T” designation denotes enhanced thermal management and expanded detector integration capability—critical for maintaining biomolecule stability during extended runs and supporting orthogonal detection strategies required for regulatory-compliant characterization.
Key Features
- Modular wet-side architecture: All fluidic components—including pumps, valves, detectors, and column ports—are front-mounted for intuitive access, rapid maintenance, and contamination-minimized workflow execution.
- Dual-pump gradient generation: Supports precise linear and step gradients with programmable flow rate ramping, ensuring optimal resolution across diverse resin chemistries and column dimensions.
- Multi-channel real-time monitoring: Integrated dual-wavelength UV absorbance (260 nm / 280 nm), conductivity, and pH detection provide simultaneous assessment of biomolecule concentration, buffer ionic strength, and mobile phase acidity—enabling immediate method adjustment and peak identification.
- Extended solvent compatibility: Certified for daily in-place cleaning (CIP) with ≥1 mol/L NaOH and ≥2 mol/L NaCl; validated for use with acetonitrile, isopropanol, and other organic modifiers—supporting both aqueous and reversed-phase applications.
- Thermally stabilized operation: Active temperature control of detector flow cells and critical fluid paths minimizes baseline drift and improves signal-to-noise ratio during prolonged analytical or preparative runs.
- Scalable pressure and flow performance: The 25T variant delivers up to 20 MPa at ≤25 mL/min for high-resolution analytical separations; the 150T variant operates up to 5 MPa at ≤150 mL/min—optimized for fast-loading and high-throughput purification of milligram-to-gram quantities.
Sample Compatibility & Compliance
The ÄKTA pure™ T system accommodates all standard laboratory-scale chromatography columns from Cytiva—including HiTrap®, Tricorn™, XK™, and HiScale™ series—and supports custom column mounting via standardized fittings and pressure-rated tubing. It complies with key international standards governing analytical instrumentation in regulated environments: ISO/IEC 17025 for testing laboratories, ASTM E2500 for equipment qualification, and FDA 21 CFR Part 11 requirements when operated with UNICORN™ software configured for audit trail, electronic signatures, and user-access controls. The system’s documented design qualification (DQ), installation qualification (IQ), and operational qualification (OQ) protocols support GLP and GMP compliance for preclinical and clinical-stage bioprocess development. Its pH and conductivity sensors are traceably calibrated per ISO 17025-accredited procedures, and UV detector wavelength accuracy is verified against NIST-traceable holmium oxide reference standards.
Software & Data Management
Controlled exclusively by UNICORN™ software (v7.0 or later), the ÄKTA pure™ T enables full lifecycle method development—from experimental design and real-time run supervision to post-run analysis and report generation. UNICORN™ provides validated, secure data handling with built-in audit trails, electronic signature support, and role-based user permissions aligned with 21 CFR Part 11 Annex 11 expectations. Raw chromatograms, method files, and instrument logs are stored in a structured, searchable database with automatic timestamping and version control. Integration with Cytiva’s BioProcess Systems suite allows seamless transfer of purification methods to larger-scale ÄKTA avant™ or ÄKTA pilot™ systems—ensuring consistent scalability from lab bench to pilot plant. Export options include CSV, PDF, and .cdx formats compatible with third-party statistical tools (e.g., JMP, GraphPad Prism) and enterprise LIMS platforms.
Applications
- Monoclonal antibody (mAb) purification: Capture (Protein A), intermediate polishing (ion exchange), and final polishing (size exclusion) in a single-platform workflow.
- Recombinant protein purification: His-tagged, GST-fused, or native protein isolation with on-line UV/Conductivity/pH profiling for yield and purity tracking.
- Oligonucleotide and mRNA purification: Desalting, buffer exchange, and removal of truncated species using anion-exchange or SEC columns.
- Virus-like particle (VLP) and extracellular vesicle (EV) isolation: Size-based separation under low-shear conditions preserving structural integrity.
- Method development and optimization: Rapid screening of gradient slopes, flow rates, and column temperatures to define robust, transferable purification protocols.
- Quality control release testing: Quantitative assessment of purity, aggregation state, and residual host cell proteins using calibrated UV response and retention time alignment.
FAQ
What chromatography techniques does the ÄKTA pure™ T support?
It supports gel filtration (SEC), ion exchange (IEX), hydrophobic interaction (HIC), affinity (e.g., Protein A, Ni-NTA), and reversed-phase (RP) chromatography—provided appropriate columns, solvents, and system configuration are used.
Can the system be qualified for GMP manufacturing?
Yes—when deployed with UNICORN™ software in validated configuration and supported by Cytiva’s IQ/OQ documentation packages, it meets requirements for Phase I–III clinical material production under current GMP guidelines.
Is remote monitoring possible?
UNICORN™ supports secure remote desktop access and real-time status dashboards via Cytiva’s cloud-connected BioProcess Insight portal—subject to local IT security policy approval.
How is detector calibration performed?
UV wavelength calibration uses NIST-traceable holmium oxide filters; conductivity and pH sensors are calibrated using certified standard solutions traceable to national metrology institutes (e.g., NIST, PTB).
What maintenance intervals are recommended?
Pump seals and check valves require inspection every 500 hours of operation; UV lamp replacement is recommended every 2,000 hours; system sanitization with NaOH is performed daily per SOP, with full CIP validation conducted quarterly.
