KNAUER AZURA® SMB Simulated Moving Bed Chromatography System

Overview

The KNAUER AZURA® SMB Simulated Moving Bed Chromatography System is a laboratory-scale, high-pressure preparative chromatography platform engineered for continuous, high-efficiency separation of binary or pseudo-binary mixtures. Unlike conventional batch chromatography—where only a fraction of the column bed actively participates in separation—the AZURA SMB implements a true continuous counter-current process by simulating the physical movement of stationary phase through synchronized valve switching and precise flow control across multiple columns arranged in four distinct zones. This architecture enables simultaneous extraction of both raffinate and extract streams with enhanced mass transfer efficiency, reduced solvent consumption, and improved resin utilization. The system operates on fundamental principles of equilibrium-controlled chromatographic partitioning under dynamic flow conditions, making it particularly suitable for applications demanding high purity, reproducible yield, and scalable process development—especially in pharmaceutical, biopharmaceutical, and food-grade purification workflows.

Key Features

• Modular 8-column configuration (2 columns per zone), fully configurable to adapt column count per zone for process optimization and scalability studies.
• Dual operational modes: standard closed-loop SMB for steady-state continuous separation and open-loop SMB for flexible feed introduction and transient process validation (e.g., fermentation broth processing).
• Integrated high-precision HPLC-grade pumps, pressure-rated up to 400 bar, ensuring stable flow delivery across all zones under varying viscosity and backpressure conditions.
• Real-time, synchronized multi-channel valve sequencing controlled via PurityChrom® MCC software—supporting full audit trail, method versioning, and user-defined event triggers.
• Compatible with a wide range of chromatographic media, including polymer-based resins (e.g., Eurokat CA for carbohydrate separation), silica-based reversed-phase and ion-exchange materials, and specialty affinity matrices for protein capture.
• Designed for GLP-compliant operation: supports 21 CFR Part 11–compliant electronic signatures, instrument calibration logging, and secure data archiving when deployed with validated software configurations.

Sample Compatibility & Compliance

The AZURA SMB demonstrates proven compatibility with both small-molecule and large-biomolecule purification workflows. For small molecules, it has been successfully applied to the continuous isolation of xylitol from fermentation broths using water as the sole eluent and Eurokat CA columns—achieving ≥99% purity and quantitative recovery. For large biomolecules, the same hardware platform supports Multi-Column Capture Purification (MCCP) mode, enabling continuous antibody (e.g., IgG) capture, wash, elution, and column regeneration in a single integrated cycle. The system meets key international standards relevant to analytical and preparative chromatography, including ISO/IEC 17025 for method validation, ASTM E2656 for SMB performance characterization, and USP guidelines for chromatographic system suitability where applicable. All fluidic components comply with FDA-compliant wetted materials (e.g., 316L stainless steel, PEEK, and fluoropolymer seals), and system design facilitates cleaning-in-place (CIP) and sterilization-in-place (SIP) protocols per GMP requirements.

Software & Data Management

PurityChrom® MCC is the dedicated control and data acquisition software for the AZURA SMB platform. It provides a unified interface for configuring zone flow rates, valve switching sequences, cycle times, and pressure monitoring across all columns. The software supports real-time chromatogram overlay, peak integration, and export of raw data in standard formats (e.g., .cdf, .csv). For regulated environments, optional validation packages enable full 21 CFR Part 11 compliance—including electronic signature enforcement, audit trail generation, role-based access control, and immutable method storage. Process analytical technology (PAT) integration is supported via analog/digital I/O ports, allowing connection to external UV/RI detectors, pH/conductivity sensors, or fraction collectors for closed-loop feedback control during MCCP or SMB runs.

Applications

The AZURA SMB serves dual-purpose roles across early-stage process development and pilot-scale manufacturing support. In small-molecule applications, it enables continuous downstream processing of bio-based platform chemicals—such as xylitol, sorbitol, or chiral intermediates—reducing solvent use by up to 50% compared to batch chromatography while maintaining >99% product purity. In biopharmaceutical contexts, its MCCP functionality replaces traditional Protein A affinity chromatography with a continuous, multi-column alternative that improves resin lifetime, cuts buffer consumption by ~40%, and eliminates hold steps between cycles. Published case studies include continuous IgG purification from clarified CHO cell harvests, where the system achieved consistent monomer recovery (>95%), host-cell protein clearance (<10 ppm), and aggregate removal (<0.5%) over 72-hour uninterrupted operation. Additional applications span nutraceutical purification (e.g., steviol glycosides), enantiomeric resolution of APIs, and recovery of oligonucleotides from synthesis waste streams.

FAQ

What is the difference between SMB and MCCP modes on the AZURA SMB system?
SMB mode implements classical four-zone continuous chromatography for binary separations, whereas MCCP mode reconfigures the same hardware into a cyclic multi-step purification train (capture, wash, elute, regenerate) optimized for large biomolecules like monoclonal antibodies.
Can the AZURA SMB be used with aqueous-only mobile phases?
Yes—validated applications include xylitol purification using water as the sole eluent on Eurokat CA columns, demonstrating compatibility with low-salt, non-organic solvent systems.
Is the system suitable for GMP manufacturing environments?
While designed for laboratory-scale development, the AZURA SMB supports GMP-aligned workflows when paired with validated PurityChrom® MCC software, calibrated instrumentation, and documented change control procedures.
How many columns can be configured per zone?
The base configuration uses two columns per zone (total eight), but the modular architecture allows scaling to one or three columns per zone depending on throughput and resolution requirements.
Does the system support automated fraction collection and real-time UV monitoring?
Yes—via optional detector integration and programmable fraction collector triggers within PurityChrom® MCC, enabling PAT-driven process control and offline analytics correlation.