Aggregates Sizer

The Shimadzu Aggregates Sizer is an advanced, high-precision system designed to facilitate the quantitative evaluation of aggregates in biopharmaceuticals. It accurately measures particle concentrations within the range of 100 nanometers (nm) to 10 micrometers (µm), expressed in micrograms per milliliter (µg/mL) or particles per milliliter (particles/mL).

Comprehensive Particle Size Analysis

Biopharmaceutical aggregates are classified based on their size:

• Nanometer: Particles smaller than 100 nm
• Submicrometer: Particles between 100 nm and 1 µm
• Subvisible: Particles ranging from 1 µm to 100 µm
• Visible: Particles larger than 100 µm

Traditionally, evaluating particles within the 100 nm to 10 µm range required multiple measurement techniques. The Aggregates Sizer streamlines this process by enabling precise, quantitative measurements across this spectrum with a single system, improving efficiency and consistency.

Key Features of the Aggregates Sizer

✅ Efficient Sample Utilization

The system requires minimal sample volumes for accurate measurements:

• Micro Cell Unit: Requires just 125 mL of sample.
• Batch Cell Unit: Requires approximately 5 mL of sample.

This efficiency minimizes waste and is particularly beneficial for high-value biopharmaceutical samples.

✅ Real-Time Aggregation Monitoring

The Aggregates Sizer is equipped with real-time measurement capabilities, allowing it to monitor and record changes in aggregate size and concentration at intervals as short as 30 seconds.

• Stress Testing: Using the batch cell, the system can analyze the aggregation process while applying mechanical stress through stirring.
• Material Evaluation: The inclusion of stirring rods made from various materials (stainless steel, glass, PEEK) allows for assessing aggregation tendencies due to different wetted surfaces.

✅ Temperature Control Functionality

Temperature can significantly influence the aggregation process. The system includes an optional temperature control function that maintains a stable environment between 20°C to 42°C, with an accuracy of ±1°C.

This ensures that aggregate formation can be analyzed under constant temperature conditions, minimizing variability in results.

✅ Regulatory Compliance

For industries adhering to strict regulatory standards, the system’s software is compliant with FDA 21 CFR Part 11 (optional). This ensures adherence to electronic records and signature protocols, promoting data integrity and security.

✅ Advanced Laser Diffraction Technology

The system leverages the laser diffraction method using a violet laser, enhancing detection sensitivity for ultrafine particles, particularly in the nanometer range.

• Accurate Particle Sizing: The system establishes a one-to-one correlation between particle size and the light intensity distribution pattern, enabling highly precise sizing.
• Enhanced Detection for Ultrafine Particles: The violet laser ensures greater differentiation in intensity patterns, improving the accuracy of measurements for particles as small as a few tens of nanometers.

✅ High Linearity and Repeatability

• The Aggregates Sizer exhibits excellent linearity in concentration measurements, ensuring consistent results across various sample concentrations.
• Its high repeatability is demonstrated with coefficient of variation (CV) values below 3% for multiple concentration conditions, ensuring reliable data consistency.

✅ High-Resolution Detection

Utilizing the Wing Sensor II, comprising 78 concentric sensor elements, the Aggregates Sizer can effectively detect scattered light intensity patterns across a wide range of particle sizes.

This ensures high-resolution detection and the ability to accurately resolve multiple peaks in complex particle size distributions.

Versatile Application Scenarios

The Aggregates Sizer is designed for various analytical scenarios, including:

• Quantitative analysis of particles in the 100 nm to 10 µm size range.
• Time-series monitoring of aggregation processes.
• Stress-testing for accelerated aggregation evaluation.
• Inhibitor assessment, such as the evaluation of L-arginine’s effectiveness in preventing protein aggregation.

Enhanced Software Capabilities

• Concentration Display Options: Displays data both in mass concentration (µg/mL) and particle count (particles/mL).
• Flexible Data Analysis: Enables evaluation of particle quantities across user-specified particle size ranges, complying with current and future regulatory requirements.

Technical Specifications

Batch Cell Unit (with Temperature Control)

• Cell Material: Quartz glass, PTFE (funnel/cap)
• Required Liquid Volume: 5 mL
• Stirrer Mechanism: Vertical motion of stirring plate
• Stirring Plate Materials: Stainless steel, glass, PEEK

Micro Cell Unit (with Temperature Control)

• Cell Material: Quartz glass, PTFE (cap)
• Required Liquid Volume: 125 μL
• Temperature Range: 20 to 42°C, constant temperature
• Temperature Control Accuracy: ±1°C

Refrigerated/Heating Circulator

• Manufacturer: JULABO
• Model: F25-ME
• Computer Control: RS-232C connection
• Dimensions and Weight: W230 mm x D420 mm x H610 mm, 31 kg
• Required Power Supply: 100 V AC, 13 A, 50/60 Hz

Why Choose Shimadzu’s Aggregates Sizer?

• Comprehensive Measurement Range: Analyze particles from 100 nm to 10 µm with a single, integrated system.
• Minimized Sample Requirements: Perform accurate analyses using minimal sample volumes, reducing waste and cost.
• Real-Time Monitoring: Track aggregation changes instantly for deeper insights into processes.
• Temperature Stability: Ensure consistent results with advanced temperature control.
• Regulatory-Ready: Achieve regulatory compliance with optional 21 CFR Part 11 software.
• High Precision: Benefit from laser diffraction technology and high-resolution detection.

The Shimadzu Aggregates Sizer represents a breakthrough in aggregation analysis for biopharmaceuticals—offering unmatched precision, efficiency, and versatility. Whether for research, quality control, or regulatory compliance, this system delivers the data accuracy and reliability required for today’s demanding applications.

👉 For more detailed information, visit Shimadzu’s official website.