Page 16 - Shimadzu SALD-7500nano

C060-E009B

Aggregation Analysis System for Biopharmaceuticals SALD-7500nano
Aggregates Sizer

The Aggregation Analysis System for Biopharmaceuticals is created by adding a
special option to the SALD-7500nano Nano Particle Size Analyzer. It permits the
quantitative evaluation of sub-visible particles (SVP) in the sub-visible region
(100 nm to 10 µm). Despite the ability of sub-visible particles (SVP) to cause Nano Particle Size Analyzer
fatal side effects in humans, such as anaphylaxis, they have been little studied SALD-7500nano
and no analytical method has been established for them. This system offers the
following three features.

1 Quantitatively evaluates SVP range aggregate concentrations
The Aggregates Sizer is able to measure 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, aggregate concentrations in the SVP (sub-visible particle) range, from 100 nm to
10 µm, can be evaluated quantitatively (in terms of µg/mL or number/mL).

Evaluation range of particle size: 40 nm to 20 µm
Concentration display range: 40 nm to 20 µm

2 Measures aggregates with high sensitivity
The Aggregates Sizer is over ten times more sensitive than Shimadzu's previous SALD series (SALD-7100) 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, not just at two stages, before and after such changes, which allows evaluating rates of
change. Using a batch cell (5 mL sample capacity), aggregation processes can be observed as samples are mechanically stimulated.

4 Evaluates effect of temperature on aggregation process
Aggregates Sizer TC temperature control system can evaluate protein aggregates under a constant temperature (20 °C to 42 °C). It enables the
evaluation of protein aggregation depending on the temperature.

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For Research Use Only. Not for use in diagnostic procedures.
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