Aggregates Sizer TC

Aggregation Analysis System for Biopharmaceuticals with Temperature Control Function

The Aggregates Sizer aggregation analysis system for biopharmaceuticals now includes a temperature controlled cell unit. Consequently, aggregates can be measured without temperature variations affecting the formation of aggregates, even for mechanical stress testing, which takes longer than regular measurements due to the batch cell stirring function involved. In addition, the micro cell size was reduced from 400 μL to 125 μL so that smaller sample quantities can be measured.

Aggregate Formation Process Can Be Determined More Quickly with an Improved Continuous Measurement Function

With the continuous measurement function, up to 200 data points can be measured successively (changes over time) at intervals as short as 30 seconds. During measurements, the system can display a real-time particle size distribution from current measurement data, in addition to the elapsed time and remaining time, and start processing the data measured thus far. This results in a quicker understanding of the aggregate formation process.

The system includes a refrigerated/heated circulator that can be used to keep the sample at a constant computer-controlled temperature within the 20 to 42°C range (with a temperature accuracy of ±1°C).
Consequently, aggregates can be evaluated under constant-temperature conditions, so that aggregate formation is not affected by any temperature changes.

Polysorbate not added

Polysorbate added

Sample Bovine gamma globulin
Solution Phosphate buffer (pH 7.4, with 150 mM NaCl) + polysorbate-20
Sample Concentration 1 mg/mL
Conditions Stirred with stainless steel stirring rod (at 5 minute intervals for 40 minutes at constant 25°C temperature)

Cell Volume Reduced to 125 μL

The amount of sample required was reduced from 400 μL to a low 125 μL by eliminating as much of the sample that does not affect measurements as possible. In addition, the micro cell material was completely changed to quartz glass, so that the cells can be cleaned chemically (alkaline) or ultrasonically.

Additional Software Functions Can Be Used to Obtain Necessary Information Quickly

Display Concentration in Terms of Count (count/mL)

In addition to the mass concentration values displayed on previous models (μg/mL),concentration can now also be displayed in terms of number of aggregates per milliliter (count/mL).

Evaluate Aggregate Quantities within Any Specified Particle Size Range

Data can be displayed for the same particle size intervals as used for current techniques (such as for particle size counters). It also can be used to evaluate the particle quantities in specific particle size intervals required by regulations and standards expected to be established in the future.

Specifications

Aggregates Sizer with Temperature Control Function
Batch Cell Unit (with Temperature Control Function)
Cell Material Quartz glass, PTFE (funnel/cap)
Required Liquid Volume Approx. 5 mL
Stirrer Mechanism By vertical motion of stirring plate
Stirring Plate Material* Stainless steel, glass, PEEK
Micro Cell Unit (with Temperature Control Function)
Cell Material Quartz glass, PTFE (cap)
Required Liquid Volume 125 μL
Temperature Range 20 to 42°C, constant temperature
Temperature Control Accuracy ±1°C
Operating Environment Temperature: 10 to 30 °C, Humidity: 20 to 80 %
Refrigerated/Heating Circulator
Manufacturer JULABO
Model F25-ME
Computer Control RS-232C connection
Dimensions and Weight W230 mm x D420 mm x H610 mm, 31 kg
Required Power Supply 100 V AC, 13 A, 50/60 Hz
 

* The system includes three types of batch cell stirring plates made of three different materials (stainless steel, glass, and PEEK) commonly used for preparing or storing biopharmaceuticals.

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

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