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GE Cytiva ÄKTA pure 150 M Protein Purification System Comprehensive Overview

The GE Cytiva ÄKTA pure 150 M is an internationally advanced medium-scale protein purification system designed for complex purification needs in biopharmaceutical process development, preclinical sample preparation, and life science research. Combining industrial-grade reliability, flexible modular configuration, and regulatory-compliant software control, this system has become a core equipment in global research institutions and pharmaceutical companies. Below is a detailed elaboration from three aspects: technical features, application scenarios, and system advantages.

1. Core Technical Features

High Throughput and Precision Pump System

The ÄKTA pure 150 M utilizes a dual-piston serial pump design, achieving a maximum flow rate of 150 mL/min (expandable to 300 mL/min in column packing mode) with an operating pressure range of 0–5 MPa. Its flow rate accuracy error is less than 0.5%, ensuring high method reproducibility and direct scalability to production levels (e.g., ÄKTA Process systems).

Multi-Dimensional Online Detection功能

The system's standard UV detector supports simultaneous monitoring of three independent wavelengths (190–700 nm), with optional secondary UV or fluorescence detectors. Integrated pH/conductivity sensors enable real-time monitoring of buffer composition and elution gradient changes, ensuring precise chromatographic process control.

Modular Flexibility

Users can configure the system with the following optional modules:

• Autosampler: Supports unmanned processing of up to 96 sample vials.

• Multi-Valve System: Connects up to 10 chromatography columns for complex multi-step purification workflows.

• BufferPro Buffer Blending Module: Automatically mixes up to 5 stock solutions to reduce manual errors.

• Fraction Collector: Supports collection triggered by time, volume, or peak shape, compatible with various container types.

Regulatory-Compliant Software Platform

Full-process automation is achieved through UNICORN™ 7.x control software, which offers:

• Method Editing and Optimization: Built-in DoE (Design of Experiments) tools and chromatography column performance database.

• Data Integrity Management: Complies with 21 CFR Part 11 requirements, supporting electronic signatures, audit trails, and permission分级.

• Remote Monitoring and Reporting: Allows remote viewing of operation status via web browsers and exports compliant reports.

2. Broad Application Coverage

Biopharmaceutical Process Development

Widely used in purification process development for monoclonal antibodies, recombinant proteins, viral vectors (e.g., AAV), and mRNA vaccines. Examples include:

• Antibody capture via Protein A affinity chromatography, combined with ion exchange chromatography for precise removal of host cell proteins and aggregates.

• Final product formulation buffer exchange and aggregate analysis using size exclusion chromatography (SEC).

Advanced Research Applications

• Membrane Protein Purification: Combined chromatography with techniques like SMALPs (styrene maleic acid lipid particles) to maintain protein stability.

• Nucleic Acid Purification: Plasmid DNA anion exchange chromatography, mRNA oligonucleotide affinity chromatography.

• Complex Studies: Tag-based affinity chromatography (e.g., HisTrap) combined with gel filtration for protein interaction analysis.

Diagnostic Reagent and Reference Material Production

Used for preparing high-purity antigens (e.g., COVID-19 Spike protein), antibody conjugates (e.g., small-scale ADC validation), and international reference material calibration.

3. System Advantages

Seamless Method Scalability

Based on fluidics design consistent with production-scale systems (e.g., ÄKTA Process), laboratory-developed methods can be directly scaled to industrial production, significantly reducing process transfer time.

End-to-End Automation and Intelligence

Full automation from buffer preparation, sample loading, chromatography separation, to fraction collection minimizes manual操作 errors. Intelligent peak recognition automatically adjusts collection triggers to improve target product recovery rates.

Stringent Compliance and Validation Support

The system provides IQ/OQ/PQ validation services (Installation/Operational/Performance Qualification). All fluid path materials comply with USP Class VI biocompatibility standards, ensuring compliance for preclinical sample production.

Low Consumable and Maintenance Costs

Utilizes reusable chromatography columns and standardized tubing designs to reduce long-term costs. The system supports CIP (Cleaning-in-Place) with 1 M NaOH, effectively preventing cross-contamination and extending service life.

Conclusion

The GE Cytiva ÄKTA pure 150 M represents the technical benchmark for medium-scale protein purification systems. Its high throughput, modular design, and compliant software not only meet the stringent requirements for purification precision and efficiency in research and industry but also provide reliable technical support for the entire lifecycle of biopharmaceuticals from lab to production. Whether for cutting-edge scientific research or commercial production development, this system delivers exceptional purification solutions.