Shimadzu’s New Aggregates Sizer Aggregation Analysis System for Biopharmaceuticals Enables Real-time Quantitative Analysis
COLUMBIA, Md., December 17, 2013 – Identifying SVP (sub-visible particle) aggregates that can cause severe side effects in biopharmaceuticals has been a longtime concern in the pharmaceutical industry. Shimadzu Scientific Instruments has introduced the Aggregates Sizer Aggregation Analysis System, which offers the first effective quantitative, high-speed evaluation of 100 nm to 10μm SVP aggregates that may be present in biopharmaceuticals.
Generation of aggregates in the sub-visible range can occur during development of biopharmaceuticals because of mechanical stimulation or temperature changes. The Aggregates Sizer is capable of covering all ranges of SVP particle size in a single measurement, and can evaluate the concentration (μg/mL) that can induce allergic systemic reactions such as anaphylaxis and other severe side effects.
The new system offers greater quality control and improved efficiency in the development of biopharmaceuticals. By enabling screening for and elimination of aggregation prone-proteins in the early stages of drug development, Shimadzu’s Aggregates Sizer will save time and reduce costs.
The Aggregates Sizer also features greater sensitivity and speed than previous size analyzers. The instrument is capable of accurately measuring micro sample quantities using disposable cells for 0.4 mL sample quantities. Size and quantity changes can be confirmed quantitatively as a concentration (unit: μg/mL) at one-second intervals, allowing real-time evaluation of rates of change and observation of aggregation processes as samples are mechanically stimulated.
Shimadzu offers a variety of software and system configuration options for a broad range of uses, environments and conditions. For more information, visit http://www.shimadzu.com/an/lifescience/bio/aggregates-sizer.html.
About Shimadzu Scientific Instruments Inc.
Shimadzu Scientific Instruments (SSI) is the American subsidiary of Shimadzu Corp., headquartered in Kyoto, Japan. Founded in 1875, Shimadzu is a $3 billion multinational corporation with three major divisions: Medical Diagnostics, Aerospace/Industrial and Analytical Instruments. In the United States, SSI has a network of more than 50 locations providing local and regional sales, service and technical support. Visit www.ssi.shimadzu.com for more information.