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Shimadzu’s New Aggregation Analysis System for Biopharmaceuticals Enables Real-Time Quantitative Analysis of Sub-Visible Particles

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Shimadzu Scientific Instruments (SSI) has introduced an Aggregates Sizer Aggregation Analysis System, the first commercially available tool to provide 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.

Sub-visible particle aggregates in biopharmaceuticals are an unintended consequence of the manufacturing process. These aggregates can induce allergic systemic reactions, such as anaphylaxis and other severe side effects if they make their way into the final product.

Based on the laser diffraction method, 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 (μg/mL).

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. In addition, 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 accelerates testing without the need for additional equipment.

WingSALD bio software features a measurement assist function that reduces operation errors by allowing users to prepare standard operating procedures to ensure measurements are always performed using the same conditions and procedures. In addition, it allows real-time simultaneous display of particle size distribution/light intensity distribution. It also features a powerful self-diagnostics function and multiple report formats.