AutoCE-3000
Fully Automated Capillary Electrophoresis System
Automation Compliance Ready High Throughput
The global biopharmaceutical industry is undergoing a structural transformation: multi-pipeline parallel development has become the norm, with a continuous emergence of novel modalities such as monoclonal antibodies (mAbs), bispecific antibodies (bsAbs), ADCs, AAVs, and mRNA. Coupled with the ICH Q14 framework for Analytical Procedure Lifecycle Management and stringent FDA/EMA requirements for data integrity and traceability, laboratories urgently require high-level automation and compliance tools. These tools are essential to address the pervasive pain points found in traditional manual and semi-automated electrophoresis workflows—namely, difficulties in method transfer, insufficient throughput, significant inter-batch variability, heavy reliance on manual intervention, and fragmented audit trails.
Against this backdrop, the fully automated CE system represents more than just an efficiency gain; it is a systematic reconfiguration of methodology. With a core design focused on intelligence, modularity, and compliance, it redefines the electrophoresis workflow from R&D to batch release.
Advantages
Key benefits for R&D and QC workflows
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Integrated Automated Workflow:
Incorporates sample loading, separation, detection, cleaning, and data analysis into a single system, completely eliminating human operational errors and achieving true unattended operation.
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Multi-Mode Compatibility:
Supports mainstream electrophoresis modes including CZE, CGE, cIEF, and LIF detection; a single instrument covers diverse applications such as protein charge variant analysis, isoelectric focusing, and nucleic acid impurity testing.
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High Throughput and Consistency:
Features automated scheduling and dynamic temperature control technology to ensure inter-batch RSD < 2%, doubling the daily throughput per unit with an open method ecosystem.
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Built-in Application Templates and Parameter Wizards:
Allows users to quickly invoke “Application Packages” to establish standardized methods, facilitating seamless method transfer from R&D to QC.
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Compliance and Data Security:
The entire system complies with 21 CFR Part 11, GMP, and ALCOA+ requirements, featuring audit trails, electronic signatures, and versioned data locking mechanisms.
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Predictive Maintenance:
Provides real-time monitoring of critical component lifespans with proactive alerts, reducing scheduled downtime and improving laboratory utilization rates.
System Advantages
Dual-Pressure System
Stability
The dual-pressure system ensures the electrophoresis process remains balanced and stable by simultaneously controlling the pneumatic pressure at both ends of the capillary. This effectively prevents peak drift and pressure fluctuations, guaranteeing consistent and reliable results. Automatic degassing and port cleaning functions reduce clogging and maintenance frequency, significantly extending capillary lifespan. Coupled with intelligent buffer switching, it achieves smooth automated operation, maintaining the system in an efficient, precise, and stable state.
Liquid-Cooled Temperature Control
Thermal Control
Achieves efficient heat exchange through circulating coolant, providing uniform temperature distribution and faster response times. Compared to air cooling, it significantly enhances separation stability and reduces thermal drift.
Optimized Capillary Cartridge
Efficiency
The distance from the capillary outlet to the detection window is approximately 7.5 cm. A longer effective capillary length significantly enhances analytical efficiency in most small molecule and protein separations.
High-Voltage Power Supply
Safety
Equipped with a self-locking function, the high-voltage power supply automatically shuts down in the event of leakage, discharge, or sudden high-current and high-voltage hazards.
Maintenance Optimization
Serviceability
The observation window allows for direct monitoring of the coolant level, and the refilling process is convenient and fast.
Other details:
- Transportation:By air if not specified.
