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Malvern Instruments Presents Solutions to Characterizing Sub-micron Protein Aggregates

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Malvern Instruments Ltd

Original Press Release

Malvern Instruments Presents Solutions to Characterizing Sub-micron Protein Aggregates

Press release date: June 20, 2014

Malvern, UK:  In an upcoming webinar on the 26th June, 2014, Malvern Instruments will present new experimental data demonstrating how Archimedes Resonant Mass Measurement (RMM) helps developers meet evolving regulatory challenges facing the biopharmaceutical industry. 'Protein aggregation - Bridging the sub micron gap' will explore how the Archimedes system enables formulators to characterize and quantify sub-visible particles within biotherapeutic formulations between 0.1 – 10 µm. By accessing this previously challenging size range, the Archimedes allows developers to meet regulatory requirements to monitor aggregate formation throughout the entire product shelf life. Register for the webinar now at

The formation of protein aggregates is a particular concern for biopharmaceuticals requiring parenteral administration because of the potential for increased immunogenicity. As a consequence, there is an expectation from regulatory agencies for developers to monitor levels of sub-visible particles present in therapeutic protein products initially and over the course of the shelf life. Presented by Dr. Matthew Brown, Product Technical Specialist - Life Sciences, Malvern Instruments Ltd, the webinar will provide an overview of the challenges involved in characterizing and quantifying these sub-visible species. Dr Brown will demonstrate how innovative Archimedes RMM technology delivers quantitative particle analysis across a dynamic size range with the specificity to distinguish between negatively buoyant protein aggregates and positively buoyant particles, such as silicone oil - a capability beyond the scope of conventional protein characterization techniques.

Archimedes counts and characterizes particles by passing a sample across micro electro-mechanical system (MEMS) sensors comprising of a cantilever which resonates with a particular frequency. Each particle which passes across the sensor causes a change in the resonant frequency, giving an accurate and precise measurement of the particle's buoyant mass – whether positive or negative - in the sample. From this measurement, the mass, size and surface area of the particle can be accurately calculated to quickly and simply deliver measurements of sample concentration, density, volume, and polydispersity. By providing advanced insight on a molecular level, the Archimedes allows users to gain the deeper understand of their formulation required to meet the evolving needs of biopharmaceutical regulation.

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Malvern and Malvern Instruments are registered trademarks of Malvern Instruments Ltd

About Malvern Instruments
Malvern provides the materials and biophysical characterization technology and expertise that enables scientists and engineers to understand and control the properties of dispersed systems. These systems range from proteins and polymers in solution, particle and nanoparticle suspensions and emulsions, through to sprays and aerosols, industrial bulk powders and high concentration slurries. Used at all stages of research, development and manufacturing, Malvern's materials characterization instruments provide critical information that helps accelerate research and product development, enhance and maintain product quality and optimize process efficiency.

Our products reflect Malvern's drive to exploit the latest technological innovations and our commitment to maximizing the potential of established techniques. They are used by both industry and academia, in sectors ranging from pharmaceuticals and biopharmaceuticals to bulk chemicals, cement, plastics and polymers, energy and the environment.

Malvern systems are used to measure particle size, particle shape, zeta potential, protein charge, molecular weight, mass, size and conformation, rheological properties and for chemical identification, advancing the understanding of dispersed systems across many different industries and applications.

Headquartered in Malvern, UK, Malvern Instruments has subsidiary organizations in all major European markets, North America, China, Japan and Korea, a joint venture in India, a global distributor network and applications laboratories around the world.

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USA contact:    
Marisa Fraser,
Malvern Instruments Inc.
117 Flanders Road,
Westborough, MA 01581-1042  USA
Tel:  +1 508 768 6400
Fax: +1 508 768 6403

Please send sales enquiries to:
Alison Vines
Malvern Instruments Ltd
Enigma Business Park
Grovewood Road, Malvern
Worcestershire WR14 1XZ  UK          
Tel: +44 (0) 1684 892456;
Fax: +44 (0) 1684 892789

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