Malvern Instruments Archimedes particle metrology system

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In the development of protein-based therapeutics it is important to monitor protein aggregates as these may compromise drug safety and efficacy by reducing the drug effectiveness and inducing immunogenic effects. It is therefore essential not only to measure the level of aggregation in a sample, but also to identify any particles found. Currently there is a gap between visible techniques, such as microscopy, and solution-based techniques such as SEC, where it is difficult to measure the level of aggregation.

Archimedes, from Malvern Instruments, is a benchtop instrument that measures particle mass, concentration and size, from a few microns down to approximately 50 nm, by means of resonant mass measurement (RMM) — a technique that enables the analysis of protein formulations below the range accessible by optical methods. The system can also differentiate between protein aggregates and silicone oil, a common contaminant originating from syringes used to deliver drugs.

Central to the device is a MEMS (microelectromechanical systems) technology sensor, allowing the rapid, sensitive and reproducible measurement of aggregates one by one. The unit is unaffected by optical and shape variations, which can hinder alternative methods. Its gentle fluidics do not disturb fragile aggregates and require small sample sizes (as little as 100 µL).

The product can accommodate high-concentration samples and high-viscosity samples (to 100 cP) without dilution, thus providing valuable insight into proteins’ behaviour in formulation. It can provide important quantitative information on biopharmaceutical formulation quality, stability, safety and efficacy early in the development and manufacturing process.