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23 Jun 2014

Malvern Instruments Presents Solutions to Characterizing Sub-Micron Protein Aggregates

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 and10 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. 

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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