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.