- Why can particle size distribution as a concentration be measured using the laser diffraction method?
- Principle of the Laser Diffraction Method by Violet Laser
- Principle of the Laser Diffraction Method by Violet Laser
Aggregates Sizer
Aggregation Analysis System for Biopharmaceuticals
Measures the concentration of 100 nm to 10 µm aggregates of biopharmaceuticals
The Aggregates Sizer aggregation analysis system enables the quantitative evaluation of particle amounts in the 0.1 µm to 10 µm range as a concentration (units: µg/mL or particles/mL)*1.
Aggregations of biopharmaceuticals can be categorized*2 into 4 ranges: nanometer (<100 nm), submicrometer (100 nm to 1 µm), subvisible (1 to 100 µm), and visible (>100 µm), according to their particle size.
Until now, particles in the submicrometer to subvisible portion of this range (100 nm to 10 µm) were generally measured by combining multiple methods.
*1 As per the categories in the USP (1787)
*2 In this system, the laser diffraction method is adopted as the principle behind the measurement of the particle size distribution.
The concentration (units: µg/mL or particles/mL) is determined after calibration using measurement results of polystyrene latex (PSL) standard particles.
| 1 | Quantitative evaluation of aggregate concentrations across a wide particle size range |
| This system enables the quantitative evaluation of the concentration of aggregates (units: µg/mL or particles/mL) from 100 nm to 10 µm in size. A wide range of particle sizes from the submicrometer to the subvisible regions can be evaluated with a single system. |
| 2 | Measures aggregates with small sample amounts |
| Measurements can be performed accurately with small sample amounts, using micro cells for 0.125 mL samples. |
| 3 | Quantitative evaluation of the aggregation process with the real-time measurement function |
| Changes in aggregates (particle size or concentration) can be measured and recorded in real time (with a 30 second minimum interval). Further, utilizing a batch cell (sample amount: 5 mL), the aggregation process can be measured while stress is applied by stirring. In addition, stirring rods made of different materials are provided, so the tendency to aggregate due to differences in wetted materials can be evaluated. |
| 4 | Temperature control function (when equipped with the Aggregates Sizer TC temperature control function) |
| Aggregate changes, which tend to depend on temperature, can be measured while a constant temperature (20 ℃ to 42 ℃) is maintained. |
| 5 | Software compliant with FDA 21 CFR Part 11 (optional) |
Особенности
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Particle concentrations (µg/mL or particles/mL) can be evaluated quantitatively using WingSALD bio, special software for the Aggregates Sizer. -
Vertical axis indicates the measured concentrations by Aggregates Size and horizontal axis indicates concentration as measurement conditions of 0.1 ppm, 0.5 ppm, 1 ppm, 5 ppm and 5 ppm. This graph shows good linearity of concentration measurement by Aggregates Sizer. -
The stable optical system used with the laser diffraction method enables accurate detection of scattered light. -
The intensity of scattered light from large particles is high and changes frequently within the forward small angle. In contract, the intensity of scattered light from small particles is very low and changes slowly within the large angle. -
The Aggregates Sizer aggregation analysis system for biopharmaceuticals now includes a temperature controlled cell unit. Consequently, aggregates can be measured without temperature variations affecting the formation of aggregates, even for mechanical stress testing, which takes longer than regular measurements due to the batch cell stirring function involved. In addition, the micro cell size was reduced from 400 μL to 125 μL so that smaller sample quantities can be measured.