GE Healthcare AKTAprocess Automated Chromatography Production System

Overview

The GE Healthcare AKTAprocess is an automated, scalable liquid chromatography production system engineered for robust, regulatory-compliant purification of biopharmaceuticals—from process development through clinical manufacturing to commercial-scale GMP production. Built upon the proven architecture of the BioProcess platform and succeeding the AKTAexplorer (1996) and AKTApilot (2002) systems, the AKTAprocess integrates core principles of preparative chromatography—including gradient elution, fraction collection, real-time UV/pH/conductivity monitoring, and column packing control—with industrial-grade hardware designed for 24/7 operation in controlled environments. Its modular fluidic design supports both polypropylene (PP) and stainless steel 316L piping configurations, enabling seamless transition from non-GMP pilot runs to fully validated manufacturing processes. The system operates under closed-loop control via UNICORN™ software—ensuring data integrity, audit trail compliance, and full traceability per FDA 21 CFR Part 11 and EU Annex 11 requirements.

Key Features

• Modular, field-upgradable architecture: Hardware and software configurations can be expanded post-installation—including additional pumps, detectors, valves, or automation modules—without system decommissioning.
• Dual-material fluid path options: PP tubing (6 bar max @ ≤40 °C) for cost-sensitive or corrosive applications; electropolished SS 316L tubing (10 bar max @ ≤40 °C for smaller IDs) for high-pressure, high-temperature, or sterile processing environments.
• Three calibrated flow rate ranges: 4–180 L/h (R&D & small-batch), 13–600 L/h (pilot & clinical), and 45–1800 L/h (commercial manufacturing), each optimized for laminar flow stability and minimal shear stress on sensitive biomolecules.
• Integrated AxiChrom® column compatibility: Enables automated, pressure-controlled column packing with real-time bed compression monitoring—critical for reproducible resin performance and long-term column lifetime.
• NEMA 4X/IP56-rated cabinet: Provides protection against dust ingress, water splashing, and corrosion—suitable for cleanroom-adjacent utility areas or dedicated manufacturing suites.
• Comprehensive regulatory documentation package: Includes FAT/SAT protocols, IQ/OQ documentation templates, 21 CFR Part 11-compliant electronic signatures, and GLP/GMP-aligned validation support services.

Sample Compatibility & Compliance

The AKTAprocess accommodates a broad range of biopharmaceutical feedstocks—including monoclonal antibodies (mAbs), recombinant proteins, viral vectors, plasmid DNA, and vaccine intermediates—across diverse chromatographic modes (e.g., Protein A affinity, ion exchange, hydrophobic interaction, size exclusion). Its sensor suite (UV absorbance at 280 nm or multi-wavelength, pH, conductivity, pressure, temperature) meets ASTM E2500-13 guidance for analytical instrument qualification. All electrical components conform to UL 508A and EN 61010-1 safety standards. The system’s firmware and UNICORN software are qualified for use in FDA-regulated environments under current Good Manufacturing Practice (cGMP) and ICH Q5/Q7 frameworks. Full traceability—including user action logs, method version history, and raw detector signal archives—is maintained with immutable timestamps and role-based access control.

Software & Data Management

UNICORN 7.x (or later) serves as the central control and data management platform. It provides deterministic real-time control of all hardware functions—including gradient formation, fraction triggering, buffer selection, and column regeneration cycles—while generating ALCOA+ compliant data (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Audit trails record every parameter change, method edit, or user login with digital signature verification. Export formats include CSV, PDF, and native .ucf files compatible with LIMS and MES integration. Optional UNICORN Connect enables remote monitoring, predictive maintenance alerts, and centralized fleet management across multiple AKTAprocess installations.

Applications

• Upstream-compatible capture step optimization using Protein A resins at pilot scale (13–600 L/h)
• Commercial-scale polishing of mAb drug substances via sequential cation-exchange and SEC steps (45–1800 L/h)
• Process validation studies requiring ≥3 consecutive successful batches under identical operational parameters
• Technology transfer between development labs and contract manufacturing organizations (CMOs)
• Continuous chromatography implementation using multi-column switching configurations
• Regulatory submission support: Generation of complete process characterization datasets aligned with ICH Q5A(R2) and Q5B guidelines

FAQ

Is the AKTAprocess suitable for GMP manufacturing environments?
Yes—the system is engineered and documented to support cGMP operations, including full IQ/OQ/PQ execution, 21 CFR Part 11 compliance, and integrated electronic batch records (EBR) readiness.

Can existing AKTApilot or BioProcess systems be upgraded to AKTAprocess functionality?
Hardware upgrades are not retrofittable due to architectural differences; however, UNICORN method libraries and process knowledge are fully portable across the AKTA platform family.

What level of technical support is provided for installation and qualification?
GE Healthcare offers factory-authorized commissioning, FAT/SAT supervision, and on-site IQ/OQ execution by certified validation engineers—with optional extended service agreements covering preventive maintenance and software updates.

Does the system support multi-column or continuous chromatography configurations?
Yes—via optional valve manifolds and synchronized pump control, the AKTAprocess supports 2-column, 3-column, and periodic counter-current (PCC) setups when paired with appropriate column hardware and UNICORN method scripting.

Are consumables and spare parts available globally?
All fluidic components—including SS 316L tubing sets, PP manifold kits, UV flow cells, and pH/conductivity sensors—are stocked through GE Healthcare’s global distribution network with documented shelf-life and lot traceability.