AKTAready Automated Industrial Chromatography System

Overview

The AKTAready Automated Industrial Chromatography System is an engineered solution for clinical-stage biopharmaceutical manufacturing and scalable process development. Designed as a core component of Cytiva’s ReadyToProcess® platform, it implements a closed, single-use chromatography architecture grounded in validated fluidic integrity and hygienic process control. Unlike traditional reusable systems requiring extensive cleaning-in-place (CIP) and sterilization-in-place (SIP) protocols, the AKTAready operates with pre-assembled, gamma-irradiated, and endotoxin-tested flow path kits—enabling rapid transition between product batches without cross-contamination risk. Its measurement principle relies on precision-controlled peristaltic and/or piston-driven pumping, coupled with real-time UV/Conductivity/pH detection and fraction collection, to deliver reproducible separation performance across dynamic flow regimes—from analytical-scale screening (50 mL/min) to pilot-scale production (510 L/hr). The system supports both affinity and ion-exchange chromatography workflows under cGMP-aligned operational constraints.

Key Features

• Modular, disposable flow path architecture with full traceability to manufacturing batch and ISO 8 cleanroom packaging
• Wide operational flow range (50 mL/min – 510 L/hr) accommodating column diameters from 70 mm to 450 mm
• Pre-validated, USP Class VI–compliant materials throughout the entire fluidic path—including tubing, connectors, sensors, and fraction containers
• Reduced downtime: complete flow path replacement executed in under 60 minutes, eliminating CIP/SIP cycles and associated validation burden
• Integrated hardware-software coordination enabling method transfer from lab-scale AKTA systems via UNICORN software compatibility
• Robust chemical resistance to common process buffers—including low-pH elution solutions, chaotropic agents, and sodium hydroxide-based sanitants

Sample Compatibility & Compliance

The AKTAready system is qualified for processing mammalian cell culture harvests, clarified lysates, and intermediate purification streams in clinical manufacturing environments. It conforms to ICH Q5A(R2) and Q5D guidelines for viral clearance validation support, and its disposable components meet ISO 10993-5 and USP <88> cytotoxicity requirements. All flow path kits are supplied with comprehensive regulatory documentation—including material declarations, extractables/leachables summaries, endotoxin test reports, and gamma irradiation dose certificates. The system design supports compliance with FDA 21 CFR Part 11 (electronic records/signatures), EU Annex 11 (computerized systems), and WHO TRS 986 Annex 5 (aseptic processing), particularly when deployed within GLP/GMP-compliant facilities undergoing audit.

Software & Data Management

Controlled by UNICORN™ software (v8.3 or later), the AKTAready enables method-driven operation with embedded audit trail functionality, user access levels, and electronic signature support compliant with 21 CFR Part 11. Method templates can be imported directly from lab-scale AKTA systems, reducing scale-up uncertainty. All run data—including pressure profiles, UV absorbance at 280 nm, conductivity, pH, and fraction triggers—are time-stamped, encrypted, and exportable in CSV or PDF formats. Raw data files are stored in a structured directory hierarchy with SHA-256 checksums for integrity verification. Optional integration with MES (Manufacturing Execution Systems) is supported via OPC UA or RESTful API interfaces for seamless batch record linkage.

Applications

• Clinical-phase monoclonal antibody (mAb) purification, including Protein A capture and polishing steps
• Viral vector purification (AAV, lentivirus) under closed, low-shear conditions
• Plasmid DNA isolation using anion exchange and size exclusion chromatography
• Process development studies requiring rapid iteration across resin types, buffer conditions, and column geometries
• Technology transfer from R&D to GMP manufacturing sites with minimized qualification effort
• Multi-product facility operations where changeover speed and contamination control are critical success factors

FAQ

Is the AKTAready system suitable for GMP manufacturing?
Yes—the system is designed for use in clinical and commercial manufacturing environments under cGMP, with full documentation packages supporting regulatory submissions.
Can existing UNICORN methods be reused on AKTAready?
Yes—method portability is maintained through backward-compatible UNICORN software versions and standardized parameter mapping.
What validation support is provided for disposable flow path kits?
Each kit includes a Certificate of Analysis, Certificate of Conformance, gamma irradiation report, endotoxin test result, and full material traceability documentation.
How is system integrity verified after flow path replacement?
Built-in leak detection, pressure hold tests, and automated priming routines confirm fluidic integrity prior to sample loading.
Does the system support PAT (Process Analytical Technology) integration?
Yes—real-time sensor outputs (UV, conductivity, pH, temperature) are accessible via analog/digital I/O and OPC UA for external PAT platform integration.