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Quanta Morphologi Delivers Direct Method Data for Critical Pharmaceutical Applications
FEI Company (NASDAQ: FEIC) and Malvern Instruments Ltd. (Malvern, UK) have released Quanta Morphologi, a powerful new solution combining the performance of FEI's Quanta FEG scanning electron microscope and Malvern's proven Morphologi particle characterization software. For the first time ever, Quanta Morphologi users, including pharmaceutical quality control method development labs, will have direct analysis methods to obtain both size and shape information on sub-micron particles.
This powerful solution will provide pharmaceutical companies greater control over new products and drug formulations that require particle manufacture at increasingly smaller nanoscale dimensions for a wide variety of advanced therapeutic applications.
"In pharmaceutical manufacturing, quality assurance and control laboratories must ensure that quality standards are constantly met for raw materials, intermediates and final products," explained Matt Harris, vice president of FEI's NanoBiology division. "Particle size and shape can dramatically alter the physical and therapeutic properties of active pharmaceutical ingredients. Until now, there have been no direct methods to characterize sub-micron particles. Combining the magnification and resolving power of the Quanta scanning electron microscope (SEM) with Malvern Instruments' industry-leading software provides a critical turnkey solution."
With Quanta Morphologi, users will be able to create reference methods for quality control process design, perform automated particle analysis, obtain surface detail, and perform statistical analysis to more fully characterize particle size and shape distributions. The most important morphological parameters for differentiating a set of samples, such as good and bad sample batches, can be defined and subtle changes in a product or process can be readily identified.
"In today's pharmaceutical industry the ‘nanonization' of poorly soluble active pharmaceutical ingredients is one of the current strategies for developing new, more potent drugs," explains Arjen Tinke, principal scientist for particle characterization at Johnson & Johnson pharmaceutical research and development in Europe. "Obviously, the size distribution analysis of these products is essential in the R&D process as well as in quality control. With Quanta Morphologi the first absolute sizing technique has become available that routinely enables the size and shape analysis of individual nanoparticles in polydisperse products."
"Quanta Morphologi is the result of our joint development partnership with FEI and we are excited by its innovative performance," commented Ulf Willen, product manager for Malvern Instruments. "We believe users will easily recognize the important benefits delivered by this solution."
The low-vacuum capability of FEI's Quanta SEMs offer users the flexibility to analyze materials without imposing many of the traditional SEM sample preparation constraints, thereby greatly extending the applicability for particle analysis. Malvern's Morphologi particle image analysis software is a proven solution already used on Malvern systems that encompass traditional optical microscopes, such as the Morphologi G3, used by many research and industrial users around the world.
The Quanta Morphologi will be featured this week at FEI's booth 1447 at the Pittsburgh Conference (Pittcon), March 1-7, in New Orleans. It will also be the focus of a special webinar sponsored by FEI and Malvern Instruments on March 19 at 2:00 p.m. eastern daylight time. Interested parties can register in advance for the webinar and obtain more information about the product at www.fei.com/ParticleAnalysis.
About FEI Company
FEI (Nasdaq: FEIC) is a world leader in pioneering industry-leading technologies and applications that deliver imaging solutions for 3D characterization, analysis and modification/prototyping with resolutions down to the sub-Ångström level. Our customers, working in advanced research and manufacturing, are supported by field-experienced applications specialists and open access to FEI’s prestigious global user network so they can succeed in accelerating nanoscale discovery and contribute to better living through new product commercialization. FEI’s NanoPorts in North America, Europe and Asia provide centers of technical excellence where our world-class community of customers and specialists collaborate on the ongoing development of new ideas and innovative solutions. FEI has sales and service operations in more than 50 countries around the world. More information can be found at: www.fei.com.
About Malvern Instruments
Malvern Instruments is a global company that develops, manufactures and markets advanced analytical systems used in characterizing a wide variety of materials, from bulk powders to nanomaterials and delicate macromolecules. Innovative technologies and powerful software produce systems that deliver industrially relevant data enabling customers to make the connection between micro (eg particle size) and macro (bulk) material properties (rheology) and chemical composition (chemical imaging). Malvern solutions are proven in sectors from cement to pharmaceuticals and support the understanding, improvement and optimization of many industrial processes. Extensive industry experience and analytical expertise enable Malvern to deliver exceptional support to customers worldwide. www.malvern.com.
This news release contains forward-looking statements that include statements about introduction of our new Quanta Morphologi product and applications. Factors that could affect these forward-looking statements include but are not limited to delays in manufacturing and shipping the product; failure of the product to perform as expected; technical problems arising during the product release phase; and problems with our suppliers and partners. Please also refer to our Form 10-K, Forms 10-Q, Forms 8-K and other filings with the U.S. Securities and Exchange Commission for additional information on these factors and other factors that could cause actual results to differ materially from the forward-looking statements. FEI assumes no duty to update forward-looking statements.
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Trish Appleton, Public Relations
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