Aggregation Analysis System for Biopharmaceuticals
Best solution for the particle size analysis of biopharmaceutical aggregations in the SVP (sub-visible particle) range
The “Aggregates Sizer” aggregation analysis system enables the quantitative evaluation of particle amounts in the SVP range as a concentration (unit: μg/mL).
Aggregations of biopharmaceuticals can be categorized into 3 ranges: IVP (In-visible Particle), SVP (Sub-visible Particle), and VP (Visible Particle), according to their particle size.
Until now, no particle size analyzer could cover the SVP range with a single measurement. Therefore, multiple methods had to be used. Aggregates Sizer completely covers the SVP range.
Aggregates Sizer has been developed based on the “Laser diffraction method”.
Calibration of concentration (Unit: μg/mL) is based on measurements results of PSL (Polystyrene latex) standard particles.
1 Quantitatively evaluates SVP range aggregate concentrations
The Aggregates Sizer is able to measure aggregates of a wide range of particles sizes, from 7 nm to 800 μm, as part of a particle size distribution (displayed with particle quantities totaling 100 %). Furthermore, aggregate concentrations in the SVP (sub-visible particle) range, from 100 nm to 10 μm, can be evaluated quantitatively (in terms of μg/mL).
|Particle size distribution measurement range: 7 nm to 800 μm
Concentration display range: 40 nm to 20 μm
2 Measures aggregates with high sensitivity
The Aggregates Sizer is over ten times more sensitive than Shimadzu's previous SALD series (SALD-7100) particle size analyzers. This means that even micro sample quantities can be measured accurately using disposable cells for 0.4 mL sample quantities.
3 Quantitatively evaluates aggregation processes at intervals as short as one second
Changes (sizes and quantities) in aggregates can be confirmed quantitatively as a concentration (unit: μg/mL) at intervals as short as one second. This allows observing the status at various intermediate stages, not just at two stages, before and after such changes, which allows evaluating rates of change. Using a batch cell (5 mL sample capacity), aggregation processes can be observed as samples are mechanically stimulated.