New Aggregates Sizer Aggregation Analysis System for Biopharmaceuticals from Shimadzu

The Aggregates Sizer Aggregation Analysis System for Biopharmaceuticals offers quantitative, high-speed evaluation of 100 nm to 10 μm SVP (sub-visible particle) aggregates that may be present in biopharmaceuticals. Capable of evaluating the concentration (μg/mL) of aggregates that can cause shock symptom or other side effects, it is ideally suited for quality control and for improving the efficiency of biopharmaceutical development.

Product features include:

1. Quantitatively evaluates SVP range aggregate concentrations
The Aggregates Sizer measures 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, it enables quantitative evaluation (in terms of μg/mL) of aggregate concentrations in the SVP (sub-visible particle) range, from 100 nm to 10 μm.

2. Measures aggregates with sensitivity 10 times higher than previous particle size analyzers
The Aggregates Sizer is over ten times more sensitive than Shimadzu's previous SALD series 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 in order to evaluate rates of change. In addition, a batch cell (5 mL sample capacity) enables observation of aggregation processes as samples are mechanically stimulated.

Shimadzu Corporation released the Aggregates Sizer Aggregation Analysis System for Biopharmaceuticals on July 10.