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September 14, 2015 | News & Notices New Metal-Free Prominence Inert LC System Ideal for Analyzing Aggregates in Biopharmaceuticals

Prominence inert LC system

Shimadzu announces the release of its Prominence inert LC system, a metal-free system ideal for analyzing aggregates or other biological macromolecules in biopharmaceuticals. The system uses PEEK resin and other non-metal materials for all surfaces of the flow lines that contact sample solutions and mobile phases. This ensures that components at risk of their activity changing due to contact with metal materials can be reliably analyzed.

Background to the Development

Biopharmaceuticals are based on biologically-derived proteins, which can denature due to effects from a wide variety of factors during their manufacturing process. If the microparticles in biopharmaceuticals combine to form aggregates, due to elapsed time, mechanical stimulation, temperature changes, or other factors, this can not only decrease drug efficacy, but even cause serious adverse effects to humans. Therefore, during new biopharmaceutical development, analyzing the aggregates, where they are separated and analyzed based on the molecular size, using size exclusion chromatography (SEC) or other methods, is critical.

Such analytical and preparatory processes for biological macromolecules use high concentrations of sodium chloride or other halogen salts as the mobile phase. In such cases, stainless steel surfaces in the instrument or flow lines can cause various problems. These include corrosion that interferes with analysis or the proteins combining with dissolved metals so that the proteins lose their original characteristics and functionality. Consequently, there has been increased demand for a metal-free LC system from biopharmaceutical quality control and development departments.

New Product Features

By using inert (resin) materials for all flow line surfaces that contact sample solutions and mobile phases, the Prominence inert LC system offers high corrosion resistance with respect to halogen ions during aggregate analysis. At the same time, it also features the high reliability, robustness, and expandability that are characteristic of Prominence high-performance liquid chromatography systems. That means it can be used with mobile phases that have high salt or acid concentrations while it inhibits the adsorption of samples with a high affinity for metals.

The system includes the new LC-20Ai inert solvent delivery pump. The LC-20Ai features a newly improved delivery control mechanism, which reduces baseline detector noise and achieves precise solvent delivery performance to enable highly reproducible aggregate analysis results. The LC-20Ai provides stable solvent delivery performance for flow rates ranging from 0.001 to 10.00 mL/min and improved operability with features such as VP functionality for supporting instrument validation and maintenance procedures.

If used in a bromic acid analysis system or combined cyanide/bromic acid analysis system, the LC-20Ai can significantly reduce the baseline noise caused by pulsation when delivering post-column reaction solution, which increases the reliability and quantitative accuracy of ppt-level high-sensitivity analysis of public drinking water quality.

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Shimadzu Prominence Inert LC System