Spotlight Particle Characterisation Measuring Sub-Visible Particulates in Biotherapeutics
Specialists at Malvern Instruments have demonstrated the application of dynamic particle image analysis to the measurement of sub-visible particulates in biological therapeutics, using the Sysmex FPIA-3000 particle characterisation system. This is an important advance since protein suspensions tend to contain sub-visible particulates that may pose health risks or affect the performance of biological therapeutics. At sizes below 10 microns, these particulates have proved difficult to characterise fully using traditional analytical techniques. This has prompted investigations into new ways of detecting the presence, measuring the size and also characterising the shape and intensity (transparency) of these particulates to ensure product safety and performance.
The Sysmex FPIA-3000 from Malvern Instruments is a dynamic particle image analysis system that incorporates optical imaging of a sample once it has been aligned by a unique sheath-flow cell. Sample alignment ensures that every single particle, from 0.8 µm to 300 µm, has its largest surface area imaged. Obtaining the maximum dimension is critical to investigations focused on safety. However, for development studies requiring further information, the system also delivers high quality, high resolution images enhanced by contrast control that enables the distinction of primary particles, foreign matter and agglomerates. This type of additional detail can provide beneficial control over the final product.
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New Advancement in Spray Drying Technology
With the addition of the Nano Spray Dryer B-90 to its already successful product line, Büchi expands today’s spray drying possibilities. This innovative technology for particle generation in the nanometer range uses minimal sample quantities and achieves the highest possible product recovery rates. The B-90 is designed to evaluate drying during the early stages of product development in the pharmaceutical, food, advanced materials, and nanotechnology industries for aqueous or solvent based formulations.
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The droplet generation is based on a piezoelectric driven actuator, which vibrates a thin, perforated membrane in a small spray cap. The membrane features an array of micron-sized holes. The actuator is driven at ultrasonic frequency, causing the membrane to vibrate, creating precisely sized droplets with very narrow droplet distribution.
The New Alternative in Particle Size Analysis
The heater technology is based on porous metal foam, providing a laminar gas flow in the drying chamber. Optimal energy input guarantees fast heating times up to 120°C, for gentle drying of heat-sensitive materials.
The dried particles are separated by an electrostatic particle collector with excellent recovery rates. It enables easy collection of small sample quantities of high value products.
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New Data on Opaque Standards for Particle Sizing
In addition to its unique performances – widest true measurements range, excellent data for fine particles, highest accuracy and precision, powerful sampling systems – the laser diffraction analyser LA-950 from Horiba Scientific now features a new powerful tool, “Method Expert”, for automatic set–up of optimum analytical conditions. “Method Expert” is an innovative software tool developed by Horiba to simplify analysis method development in laser diffraction.
Many parameters should be studied to optimise a distribution size analysis. This tool has been created to enable one to build methods with a more scientific approach and optimise the best analytical conditions. Each measurement features a specific parameter and provides an explanation of the test purpose and procedure as well as Expert Advice for interpreting the results.
Parameters tested include: refractive index selection, ultrasonic dispersion, concentration and circulation speed. From these parameters, software will automatically perform several successive measurements to make this study. For each parameter type selected, a graph with their trends can be displayed and this allows a very quick selection of the best parameters to be used.
With Expert Advice, users will select the best conditions for their material which in turn automatically generates a sequence file providing one-button. This new revolutionary tool will simplify everyday work for laser diffraction users and will contribute to more consistent analysis results, thanks to a very scientific approach for method development.
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At Powtech 2010 Whitehouse Scientific will exhibit the company’s new opaque standards for particle size analysis. Managing Director Dr Graham Rideal will also present a lecture as part of the World Congress on Particle Technology (WPCT6), a scientific congress which this year takes place alongside Powtech. He will focus on the latest trends in particle size standards, from sub-micron multimodal standards to Image Analysis standards up to 2mm in size.
Whitehouse Scientific’s new silver-coated opaque standard covers the size range from 19 to 190 microns. It has been the subject of a recent round-robin exercise involving examination by leading particle sizing laboratories and instrument manufacturers. Importantly, the new standard has been analysed within the Quality Audit Scheme of independent company LGC Standards, and has produced the best ever repeatabilites seen by laser diffraction analysers.
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