Malvern Mastersizer 3000 for rapid biopharmaceutical drug development and manufacturing

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The measurement of particle size and particle size distribution is essential in the development and the manufacture of pharmaceutical products such as vaccines and therapeutics. Whether optimising drug formulations using the active ingredient (API), excipients and raw materials, or checking quality attributes like bioavailability, product stability and content uniformity, the particle size distribution will influence the overall performance or bioavailability of the drug.

The larger the surface area of a particle, the greater its solubility and dissolution rate, leading to increased bioavailability and a faster-acting drug release. The finer the particle size, the more cohesive and prone to aggregation over time it becomes leading to poorer colloidal stability. This in turn affects the activity of the drug as particle size distribution increases over time, making the product less efficient.

There are now a range of particle size analysis tools that are available to support pharmaceutical development. One widely used technique for particle size analysis within the pharmaceutical industry is laser diffraction using the Malvern Mastersizer 3000.

The Mastersizer 3000 delivers high performance across a wide particle size range for wet and dry dispersions from 10 nm to 3500 µm, with rapid measurement times and robust results. The Aero S dry powder dispersion accessory minimises particle breakage by avoiding impaction surfaces, allowing even the most fragile of pharmaceutical materials — including crystalline active ingredients — to be properly measured. From method development through to routine measurement, embedded expert guidance and real-time feedback should help simplify analysis and increase manufacturing efficiency.

To join Malvern’s web-based laser diffraction masterclass training series, click here.