Aggregates Sizer

Aggregation Analysis System for Biopharmaceuticals

Aggregates Sizer

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.

Aggregates Sizer by laser diffraction method


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)


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