Cytiva AKTA process Automated Upgradable Liquid Chromatography System for Bioprocessing

Overview

The Cytiva AKTA process is a fully automated, scalable liquid chromatography system engineered for robust, reproducible purification of biopharmaceuticals—from late-stage process development through clinical manufacturing and commercial-scale production. Built upon the proven architecture of the BioProcess™ platform and refined since its 2005 launch, the AKTA process implements classical liquid chromatography principles—including frontal analysis, gradient elution, and step elution—using high-precision peristaltic and/or piston-based pumping, real-time UV/ conductivity/pH detection, and integrated fraction collection. Its modular design supports both fast protein liquid chromatography (FPLC) and process-scale liquid chromatography (PS-LC), enabling seamless technology transfer from lab to pilot plant and beyond. The system operates under laminar flow conditions compatible with standard packed-bed chromatography media (e.g., Sepharose®, Capto™, and SOURCE™ resins), and is validated for use with stainless steel or polypropylene fluidic paths depending on pressure and chemical compatibility requirements.

Key Features

• Modular hardware architecture supporting field-upgradable configurations—pumps, detectors, valves, and fraction collectors can be added or replaced without system decommissioning.
• Dual tubing path options: chemically resistant polypropylene (PP) for low-pressure applications (≤6 bar) and electropolished AISI 316L stainless steel for high-integrity, high-pressure operations (≤10 bar).
• Three standardized flow rate modules (4–180 L/h, 13–600 L/h, 45–1800 L/h) calibrated per ISO 8573-1 for consistent volumetric accuracy across operational ranges.
• Native integration with AxiChrom™ pre-packed and custom-packed chromatography columns—including automated column packing verification and bed height monitoring via integrated pressure and flow sensors.
• UNICORN™ software v7.5+ provides deterministic sequence execution, method versioning, and built-in validation templates aligned with ICH Q5A/Q5D and WHO TRS 992 Annex 5 expectations.

Sample Compatibility & Compliance

The AKTA process accommodates clarified harvests, cell culture supernatants, and intermediate purified pools from mammalian, microbial, and viral vector processes. It supports all major chromatographic modes—including ion exchange (IEX), hydrophobic interaction (HIC), size exclusion (SEC), affinity (e.g., Protein A), and multimodal separations—across resin particle sizes from 15 µm to 150 µm. Fluid contact materials comply with USP Class VI and FDA 21 CFR 177.2420 for single-use and reusable components. When deployed in regulated environments, the system supports full 21 CFR Part 11 compliance—including role-based user authentication, electronic signature workflows, immutable audit trails, and data integrity controls per ALCOA+ principles. Documentation packages include IQ/OQ protocols, risk assessments (per ISO 14971), and traceable calibration records.

Software & Data Management

UNICORN™ serves as the central control, visualization, and data governance layer. It enables method development via intuitive drag-and-drop sequence builders, real-time overlay of multi-channel signals (UV 280/254 nm, conductivity, pH, temperature, pressure), and automatic peak integration using second-derivative algorithms. All raw data are stored in vendor-neutral .chf binary format with embedded metadata (method name, operator ID, timestamp, instrument ID). Export options include CSV, PDF reports, and direct interfacing with LIMS or MES systems via OPC UA or RESTful API. Electronic records meet long-term archival requirements per EU Annex 11 and FDA Data Integrity Guidance (2018).

Applications

• Monoclonal antibody (mAb) capture and polishing steps in cGMP manufacturing suites.
• Plasmid DNA and mRNA purification workflows for vaccine and gene therapy programs.
• Process characterization studies including residence time distribution (RTD) analysis and dynamic binding capacity (DBC) determination.
• Scale-down model validation for Quality-by-Design (QbD) submissions to EMA and FDA.
• Automated cleaning-in-place (CIP) and sanitization cycles with programmable flow reversal and hold-time logic.

FAQ

Can the AKTA process be qualified for GMP manufacturing?
Yes—when installed with documented IQ/OQ protocols, UNICORN™ configured for 21 CFR Part 11 compliance, and operated under controlled change management procedures, the system meets GMP requirements for Phase III and commercial production.
Is remote monitoring supported?
Yes—via UNICORN Connect, users can securely access real-time status, alarms, and historical trends through web browsers or mobile devices using TLS 1.2 encryption and SAML 2.0 identity federation.
What validation documentation is provided?
Cytiva supplies a comprehensive Validation Support Package including FAT/SAT checklists, URS templates, risk assessment summaries, and electronic copies of calibration certificates traceable to NIST standards.
How does the system handle buffer preparation and delivery?
Optional integrated buffer blending modules (e.g., AKTA process Buffer Blending Unit) enable on-demand mixing of up to four stock solutions with gravimetric feedback control and pH/conductivity verification prior to injection.
Is training included with purchase?
Standard installation includes two days of on-site operator and administrator training covering method creation, routine maintenance, troubleshooting, and compliance reporting workflows.