Shimadzu's new preparative chromatography systems promises high-performance purification

Shimadzu, one of the world leaders in analytical instrumentation, has introduced two new systems for preparative purification of samples and synthesis products. The new instruments address the special challenges of the pharmaceutical industry and are powerful tools for the food industry. The Nexera Prep series for preparative HPLC (high-performance liquid chromatography) is a method for isolating and purifying specific substances from (complex) samples mixtures. The second system, Nexera UC Prep, is a preparative SFC device (chromatography with supercritical CO₂) with extraordinary fractionation efficiency and compact design. For this reason, the Nexera UC Prep was awarded with the 2019 Pittcon Gold Excellence Award for high innovation.

Nexera Prep: a flexible system for preparative HPLC

This modular and thus very flexible instrument can be individually adapted to the needs of the user and provides support with software tools in developing new separation methods. For example, this is interesting for applications in the pharmaceutical, chemical and food industries.

The easy to scale sample separation from analytical to preparative scale and the automatic function for analytical purity control of each fraction significantly improve the productivity of this preparative HPLC system.
 
Preparative HPLC with tailored instrument configuration

The Nexera Prep series consists of several modules which build the preparative HPLC system. Users can choose from different pumps, samplers, and detectors to configure the system to meet their needs. A central module of the Nexera Prep is the LH-40 Liquid Handler or the FRC-40 Fraction Collector. These components allow the fractionation of substances into fractionation containers of various size and shape, while the liquid handler can also re-inject samples and fractions for purity control. Dedicated containers can be used as sample racks, for example, with 3240 test vials (10 mm inner diameter), small HPLC vials, or even large storage bottles, so that each fraction receives an appropriately large template. Up to six analytical columns, two preparative columns and four switching valves can be installed using the new column cabinet. The Shim-pack Scepter column for analytical and preparative work completes the Nexera Prep series and makes upscaling of analytical methods even easier by using the same column material for both scales.

Nexera UC Prep for (semi) preparative SFC

The Nexera Semi-Prep SFC solution was developed in close cooperation with the Enabling Technologies Consortium (ETC), a consortium of pharmaceutical and biotech companies in the United States. The ETC strives to speed up the processes to develop new technologies for the industry. They work with players like Shimadzu to discuss ideas and share information to implement new solutions. The project to develop a new and improved prep SFC device was initiated in 2015 and based on Shimadzu's expertise, resources and innovation. Therefore, ETC decided to develop the Nexera UC Prep with Shimadzu as its preferred partner.

"The Nexera UC Prep is an improved purification system that meets the specifications and needs of SFC users in the pharmaceutical industry," said Dr. Mirlinda Biba, Principal Scientist at Merck & Co. Inc. and project manager at ETC. "This new generation of devices meets the demand for an efficient and robust prep-SFC system with better hardware and software."

Highest performance, flexible system configuration

Key features of the Nexera UC Prep are the space-saving design and the significant increase in fractionation efficiency compared to previous prep SFC devices on the market. The Nexera UC Prep can be configured according to the customer's requirements, thus ideally integrating into existing processes and reducing timeconsuming steps in the laboratory. Furthermore, the user-friendly software control is fully integrated into Shimadzu's LabSolution software so that users avoid learning new software. This is not yet the case with manufacturers of other SFC systems.

Nexera Prep SFC specializes in nested injections, which can significantly increase sample throughput for large sample volumes on a gram scale. In this configuration up to nine fractions can be fractionated by the FRS-40 sample collector. In addition, this module not only collects the fractions, but also injects the samples into the prep SFC system.

As an alternative to the FRS-40, up to 540 fractions (10 ml vials) can be collected with the FRC-40 SF and the new and patented "LotusStream" gas-liquid separator (GLS). This special component in the fraction collector significantly increases the fractionation efficiency up to 96% and significantly reduces carry-over because the GLS can be rinsed very quickly and economically after the run. This was previously not possible with vortex or centrifugal gas liquid separators. The outstanding strength of the FRC-40 SF is in the isolation and identification of byproducts in pharmaceutical products, as the LotusStream GLS can carry a large number of small fractions in very high yields. Thus, a simple structure elucidation of the impurities is possible without further complicated specimen preparation and concentration.

A key advantage of SFC is the drastically reduced cost of hazardous solvents used in normal phase prep HPLC, for example. In addition, the Prep SFC offers reduced sample purification and drying times of the fractions compared to conventional preparative HPLC. New for the Nexera Prep SFC are the flexible configuration, the combined injector/fraction collector, and the CO2 pump with integrated cooling unit, which needs less space in the laboratory and can be used as a benchtop system.

On the software side, the newly developed "PrepSolution" software is fully integrated into Shimadzu's LabSolutions and ensures user-friendly operation, allowing users to work with different Shimadzu HPLC and SFC devices in one software.

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