Shimadzu introduces the Aggregates Sizer Aggregation Analysis System, which provides real-time quantitative evaluation of 100 nm to 10 μm sub-visible particle (SVP) aggregates. By screening and identifying aggregation-prone proteins in early-stage drug development, manufacturers can save time and reduce costs.

The Aggregates Sizer is capable of identifying all ranges of SVP particles from invisible to visible, in a single measurement in micro-sample quantities as small as 0.4 mL. It also enables quantitative evaluation of the concentration of those aggregates.

In addition, the Aggregates Sizer can execute ongoing measurements in intervals as short as one second, allowing users to evaluate rates of change at intermediate stages during the manufacturing process. A batch cell (5 mL sample capacity) enables observation of aggregation processes as samples are mechanically stimulated. This helps prevent the formation of aggregates during drug manufacturing and improves testing without the need for additional equipment.

Analytical Instrumentation

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Biopharmaceutical Analysis

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BioPharm International-04-01-2014

Aggregation System Improves Analysis of Sub-Visible Particles