Cytiva AKTAready™ Fully Automated Industrial Chromatography System

Overview

The Cytiva AKTAready™ Fully Automated Industrial Chromatography System is an engineered solution for scalable, robust, and regulatory-compliant purification of biopharmaceuticals during clinical-stage manufacturing (Phase I–III) and early commercial production. Built upon Cytiva’s proven AKTA platform architecture, the AKTAready™ integrates single-use fluidic technology with high-precision chromatographic control to eliminate traditional cleaning-in-place (CIP) and sterilization-in-place (SIP) requirements. Its core operational principle relies on pressure-driven liquid chromatography—specifically fast protein liquid chromatography (FPLC)—with real-time UV, conductivity, pH, and temperature monitoring to ensure consistent separation performance across process scales. The system is purpose-built for applications involving monoclonal antibodies (mAbs), viral vectors, plasmid DNA, and other sensitive biologics where product integrity, traceability, and contamination control are non-negotiable.

Key Features

• Pre-sterilized, disposable ReadyToProcess™ Flow Kits manufactured under ISO 8 cleanroom conditions and qualified per AOF (Assessment of Overall Fitness) protocols
• Wide dynamic flow range: 50 mL/min (for analytical/column screening) up to 510 L/hr (for pilot-scale processing), supporting column IDs from 70 mm to 450 mm
• Full chemical compatibility with common bioprocessing buffers—including low-pH elution solutions, caustic sanitants (e.g., 0.1–1.0 M NaOH), and organic solvents used in cleaning validation
• USP Class VI-certified wetted materials throughout the fluid path, with full batch traceability from raw material sourcing to final packaging
• Integrated sensor suite: dual-wavelength UV absorbance (280/260 nm), conductivity, inline pH, and temperature monitoring within the flow cell
• Modular hardware design enabling rapid kit swap-out in under 60 minutes—no disassembly, no validation requalification required between batches

Sample Compatibility & Compliance

The AKTAready™ is validated for use with a broad spectrum of biopharmaceutical feedstocks, including clarified mammalian cell culture harvests, microbial lysates, and viral vector supernatants. Its single-use architecture inherently prevents carryover and eliminates the need for cleaning validation—a critical advantage for multi-product facilities operating under cGMP. All wetted components comply with USP and cytotoxicity testing, and material certifications include FDA 21 CFR 177.2600 (food-contact polymers) and ISO 10993-5 biological evaluation. Documentation packages include Installation Qualification (IQ), Operational Qualification (OQ), and Risk Assessment Summary Files (RSF), supporting compliance with ICH Q5A(R2), Q5D, and EU Annex 1 requirements for sterile bioprocessing.

Software & Data Management

Controlled by UNICORN™ software v9.x, the AKTAready™ delivers comprehensive data governance aligned with FDA 21 CFR Part 11 and EU Annex 11 standards. The software includes built-in installation wizards for ReadyToProcess™ kits, automated method transfer tools, and context-sensitive guidance for column packing, equilibration, and gradient programming. Audit trails record all user actions, parameter changes, and system events with immutable timestamps. Electronic signatures are enforced for critical operations such as method start, fraction collection, and report generation. Data export supports CSV, PDF, and native .uwp formats compatible with enterprise LIMS and MES integration.

Applications

• Clinical supply chain support: Rapid transition from benchtop (AKTA Pure) to pilot-scale (AKTAready™) without method redevelopment
• Process characterization studies: High-throughput evaluation of binding capacity, wash stringency, and elution profiles under GMP-like conditions
• Viral vector purification: Capture of AAV or lentivirus using affinity or ion-exchange resins with minimized aggregation risk
• Plasmid DNA polishing: Anion-exchange chromatography under non-denaturing conditions with real-time dsDNA quantification
• Multi-product facility flexibility: Switching between mAb capture and vaccine antigen polishing within a single shift

FAQ

Is the AKTAready™ suitable for regulatory submissions?
Yes—the system is supported by full qualification documentation (IQ/OQ), material traceability records, and RSF files designed to meet FDA, EMA, and PMDA expectations for Phase II/III clinical manufacturing.
Can existing UNICORN™ methods be transferred directly to AKTAready™?
Yes—UNICORN™ ensures method portability across the AKTA family; parameters such as gradient slope, flow rate, and fraction triggers retain identical logic and scaling behavior.
What validation support is provided for ReadyToProcess™ Flow Kits?
Each kit includes lot-specific certificates of analysis (CoA), extractables/leachables data, and endotoxin testing reports per USP , with full AOF documentation available upon request.
Does the system support remote monitoring and alarm notification?
Yes—via UNICORN™ Connect, users can configure email/SMS alerts for pressure excursions, UV baseline drift, or buffer depletion, with secure cloud-based access enabled through TLS 1.2 encryption.
How is system performance verified after each kit change?
The UNICORN™ installation wizard executes automated system suitability tests (SST), including flow accuracy verification, UV lamp intensity calibration, and conductivity cell zeroing—results are logged and reportable.