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Cytiva ÄKTA pure™ 150T Modular Chromatography System

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Brand Cytiva
Origin Sweden
Model ÄKTA pure™ 150T
Maximum Flow Rate 150 mL/min
UV Detection Wavelengths Fixed at 260 nm and 280 nm
Software Platform UNICORN 7
Column Switching Capacity Up to 10 columns via optional column selection valve
Regulatory Compliance Designed for GLP/GMP environments

Overview

The Cytiva ÄKTA pure™ 150T is a modular, high-performance liquid chromatography (HPLC) system engineered for scalable protein purification in research, process development, and early-stage biomanufacturing. It operates on the principle of gradient-elution liquid chromatography, utilizing precise pump control, real-time UV absorbance detection, and programmable fraction collection to resolve complex biomolecular mixtures—including monoclonal antibodies, recombinant proteins, viral vectors, and plasmid DNA—based on physicochemical properties such as size, charge, hydrophobicity, or affinity. The system’s core architecture integrates dual-wavelength UV monitoring (260 nm and 280 nm) to enable simultaneous tracking of nucleic acid and protein elution profiles, supporting orthogonal purity assessment without hardware reconfiguration. Its flow range (up to 150 mL/min) accommodates analytical-scale screening through pilot-scale purification (e.g., 2.6 × 30 cm columns), while its pressure limit of 20 MPa ensures compatibility with modern high-resolution resins such as Cytiva’s Capto™ and SOURCE™ media.

Key Features

  • Modular hardware design enabling field-upgradable configurations—from basic gradient systems to fully automated multi-column platforms
  • Dual fixed-wavelength UV/Vis detector (260 nm & 280 nm) with integrated reference channel for baseline stability and drift compensation
  • High-precision dual-piston pump delivering flow accuracy ±0.5% and gradient precision ±0.2% over 0–100% B solvent range
  • Column selection valve (U9-T compatible) supporting up to 10 independent column positions for sequential or parallel purification workflows
  • Integrated fraction collector with customizable tube rack recognition, position-based triggering, and weight-based collection logic
  • UNICORN 7 software with method templates, drag-and-drop sequence building, and embedded calculation tools for yield, purity, and recovery quantification

Sample Compatibility & Compliance

The ÄKTA pure™ 150T is validated for use with standard chromatographic media across ion exchange (IEX), size exclusion (SEC), hydrophobic interaction (HIC), and affinity (e.g., Protein A, GST, HisTrap) chemistries. It accepts column dimensions from 0.5 × 5 cm (analytical) to 2.6 × 30 cm (preparative), with inlet/outlet tubing compliant with ISO 8536-4 and USP Class VI-certified materials. System validation documentation aligns with ASTM E2500-13 (Good Practice for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems) and supports IQ/OQ/PQ execution per GAMP 5 guidelines. UNICORN 7 provides full 21 CFR Part 11 compliance—including electronic signatures, role-based access control, and immutable audit trails—for regulated environments operating under FDA, EMA, or PMDA oversight.

Software & Data Management

UNICORN 7 serves as the central operational and data governance platform. It features method versioning with automatic metadata tagging (user, timestamp, instrument ID, calibration status), export of raw chromatograms in .chm format (compatible with third-party analysis tools such as Chromeleon and Empower), and batch report generation compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Data integrity safeguards include write-protected archive folders, configurable retention policies, and integration with enterprise LIMS via RESTful API. For existing ÄKTA pure™ L users, the U9-T UV detector upgrade kit enables seamless migration to dual-wavelength capability without software license renewal.

Applications

  • Multi-step purification of therapeutic proteins under non-denaturing conditions
  • Process characterization studies requiring reproducible gradient elution across >100 runs
  • Host cell protein (HCP) and DNA clearance profiling using SEC-MALS or IEX-HPLC coupled with ELISA/WB confirmation
  • Plasmid DNA purification for mRNA vaccine production, including open circular vs. supercoiled isoform resolution
  • Method development for continuous chromatography via integration with external column switching manifolds
  • Academic and industrial training platforms due to intuitive interface and comprehensive online help system

FAQ

Can the ÄKTA pure™ 150T be used for GMP manufacturing?

Yes—when deployed with UNICORN 7 in validated configuration and supported by documented IQ/OQ/PQ protocols, it meets requirements for Phase I–III clinical material production.
Is the 260/280 nm dual detection suitable for RNA purification?

Yes—the fixed wavelengths are optimized for nucleic acid (260 nm) and aromatic amino acid (280 nm) quantification, enabling real-time A260/A280 ratio monitoring during RNA or mRNA capture steps.
What column formats are supported out of the box?

Standard 10–50 mm inner diameter columns with 1/16″ Swagelok® or Cytiva QuickConnect™ fittings; custom adapters available for larger-bore or packed-bed cartridges.
Does the system support pH gradient formation?

Yes—via optional pH probe integration and UNICORN 7’s pH-controlled fraction collection module, enabling pH-triggered elution in ion exchange applications.
How is data backup handled in UNICORN 7?

Automatic daily backups to network drives or NAS devices are configurable; encrypted archive files include method parameters, raw signals, and user annotations in a single self-contained package.

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