Cytiva ÄKTA™ avant 150 Preparative Chromatography System

Overview

The Cytiva ÄKTA™ avant 150 Preparative Chromatography System is an engineered platform for scalable method and process development in protein purification. Designed around the principles of low-pressure liquid chromatography (LPLC), it employs precise gradient formation, real-time multi-parameter monitoring, and robust fluidic control to support ion exchange chromatography (IEX), size exclusion chromatography (SEC), hydrophobic interaction chromatography (HIC), and reversed-phase chromatography (RPC). Its architecture integrates high-flow capability (up to 150 mL/min, extendable to 300 mL/min in column packing mode) with pressure-limited operation (0–5 MPa), making it suitable for both analytical-scale screening and preparative-scale column packing—particularly for columns up to 5 cm internal diameter. The system operates under UNICORN™ software, which provides deterministic, audit-ready control logic compliant with GLP and GMP environments. All hardware modules—including dual-piston pumps, multi-port valves, integrated detectors, and refrigerated fraction collection—are co-engineered to ensure mechanical synchronization, minimal carryover, and thermal stability during extended runs.

Key Features

• High-flow modular pump system: Dual-piston system pump delivering stable, low-pulse flow across full range (0.01–150 mL/min); accuracy ±1.5%, precision RSD <0.5% under defined viscosity and pressure conditions.
• Integrated multi-parameter detection: UV-Vis detector with selectable pathlengths (0.5, 2, or 10 mm), real-time 190–700 nm spectral monitoring (up to 3 wavelengths simultaneously); conductivity detector with temperature compensation; pH detector with in-line calibration port and ±0.1 pH accuracy (pH 2–12).
• Five-position column selector valve: Enables automated column screening with integrated pressure sensing (inlet and outlet), Δp calculation, reverse-flow capability for backflushing or reverse elution, and bypass function for system cleaning.
• BufferPro-enabled quaternary valve: Supports automatic buffer blending from four stock solutions, eliminating manual titration and reducing preparation variability.
• Refrigerated fraction collector: Temperature-controlled (4 °C typical), accommodates up to six interchangeable racks for tubes (3–50 mL) or microplates (24/48/96-well); features DropSync™ (for ≤2 mL/min on ÄKTA avant 25 only) and reservoir-based overflow mitigation at higher flow rates.
• Comprehensive safety architecture: Integrated air sensors at sample inlet and buffer valves; dual pressure sensors on column valve and pumps; automatic run pause on air detection or pressure exceedance; optional pressure–flow regulation for dynamic flow adjustment.

Sample Compatibility & Compliance

The ÄKTA™ avant 150 supports a broad range of biomolecular samples—including monoclonal antibodies, fusion proteins, enzymes, and viral vectors—across diverse purification chemistries. Its fluidic path is constructed from biocompatible, chemically resistant materials (e.g., PEEK, stainless steel, sapphire) validated for compatibility with 1 mol/L NaOH (≥3 h/day in-place cleaning), 2 mol/L NaCl, and organic solvents including acetonitrile and isopropanol. Regulatory alignment includes built-in support for FDA 21 CFR Part 11-compliant electronic signatures and audit trails via UNICORN software, with configurable user roles, method locking, and electronic batch records. System validation documentation adheres to ISO 9001 and ICH Q5A/Q5B guidelines, and routine operation meets ASTM E2500-13 (good practice for verification of automated systems) and USP (analytical instrument qualification).

Software & Data Management

UNICORN™ software serves as the unified control and data management layer, structured into four interoperable modules: System Management, Method Editor, System Control, and Result Analysis. The Method Editor supports phase-based method construction using a drag-and-drop interface and a validated Phase Library containing preconfigured steps for equilibration, loading, washing, elution, regeneration, and sanitization. Experimental Design (DoE) integration allows statistically informed parameter sweeps—reducing total experimental runs while maximizing information yield. All runs generate time-stamped, immutable datasets with embedded metadata (instrument ID, operator, method version, environmental logs). Data export complies with ASTM E1578-20 (standard guide for laboratory information management systems) and supports CSV, PDF, and proprietary .u2 format for traceable reprocessing. Audit trail functionality records all user actions, method modifications, and system events with tamper-proof timestamps—fully compliant with ALCOA+ principles.

Applications

The ÄKTA™ avant 150 is routinely deployed in upstream-downstream process development workflows, including: (1) High-throughput resin screening for IEX and multimodal chromatography; (2) Scale-up studies from 1 mL to 100 mL column volumes; (3) Buffer optimization and gradient profiling for peak resolution enhancement; (4) In-process monitoring of critical quality attributes (CQAs) such as aggregate content (via SEC), charge variants (via IEX), and host cell protein clearance; (5) Automated cleaning-in-place (CIP) and sanitization validation; (6) Support for Quality-by-Design (QbD) initiatives through DoE-driven parameter space mapping. Its modularity also enables integration into automated lab platforms via OPC UA or Ethernet/IP protocols.

FAQ

What is the maximum column volume supported by the ÄKTA™ avant 150?

The system is optimized for columns up to 5 cm internal diameter and 20 cm bed height (≈390 mL column volume), with flow rates dynamically adjusted to maintain linear velocity consistency.
Can the system perform pH gradient elution?

Yes—via the integrated pH valve and BufferPro-enabled quaternary valve, enabling precise online mixing of pH-adjusted buffers without external dilution or manual intervention.
Is UNICORN software included with the system?

Yes—UNICORN 7.x or later is supplied as standard, including perpetual license for one workstation and remote access capability via secure VPN.
How is method transfer ensured between ÄKTA™ avant 25 and ÄKTA™ avant 150?

UNICORN methods are fully portable; scale-up is achieved by preserving residence time, gradient slope (%/min), and linear velocity—automatically recalculated by the software based on column geometry and flow rate.
Does the system support 21 CFR Part 11 compliance out-of-the-box?

Yes—UNICORN’s electronic signature workflow, role-based access control, and immutable audit trail meet core Part 11 requirements; full validation support packages (IQ/OQ/PQ protocols) are available upon request.