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July 11, 2013 | News & Notices New Aggregates Sizer Aggregation Analysis System for Biopharmaceuticals Enables Real-time Quantitative Evaluation of 100 nm to 10 µm SVP (sub-visible particle) Aggregates

The Aggregates Sizer Aggregation Analysis System for Biopharmaceuticals

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

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.

Background to Development

Biopharmaceuticals are essential to modern medicine, accounting for four of the top five products in 2012 drug sales, and the market is expected to reach $ 210 billion by 2015*. However, the generation of SVP aggregates in the sub-visible range due to mechanical stimulation or temperature changes, and the severe side effects that this induces, such as anaphylaxis (allergic systemic reactions), are concerning. Until now, no effective SVP aggregate analysis technique has been established. Shimadzu's new system significantly reduces costs and development times by allowing samples to be evaluated for aggregation at the early stages of biopharmaceutical development. In addition, it allows aggregation-prone proteins to be screened and eliminated in advance.

* Source: Cedium strategic data site

Features of the New Product

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.