Resonant Mass Measurement (RMM, Archimedes)
Coriolis Pharma is the first contract laboratory worldwide to offer analytical services of biopharmaceuticals by Resonant Mass Measurement (RMM) - Archimedes, a novel technique for subvisible particle analysis and the discrimination between silicone oil droplets and proteinaceous particles.
In RMM particles are drawn in their native suspensions through a MEMS (MicroElectroMechanical Systems) fabricated microfluidic channel which resonates mechanically. The presence of a particle in the sensor changes the total mass and shifts the sensor resonant frequency. The shifts are measured as each individual particle passes through the sensor, and particle mass is obtained with a resolution of 1 femtogram.
From these mass measurements, the corresponding size distributions are derived by translating the mass of each particle to equivalent circular diameter using the density of the particles measured. Theoretically, a size range from about 300 nm to 5 μm can be measured by Archimedes. The practical size-range depends on the density of the analyzed particles and is approximately 300 nm to 5 µm for proteinaceous particles and 500 nm to 5 µm for silicone oil droplets.
One of the main advantages of this promising technique is the fact that it is based on a completely novel measurement principle and therefore it can be truly considered an orthogonal method to the currently existing techniques for subvisible particle characterization.
Perhaps even more significant is the possibility that RMM offers for discrimination between negatively buoyant particles (particles denser than the aqueous formulation) and positively buoyant particles (particles less dense than the aqueous formulation). The latter may become particularly useful in products packaged in pre-filled syringes where both particles denser than water (proteinaceous and extrinsic particles) as well as particles less dense than water (silicone oil droplets) are typically present. A representative publication on differentiation of protein particles and silicone oil droplets has been published recently, using both MFI and Archimedes (RMM) in a comparative study.
Need to know:
Required sample amount ~ 300 µl for a single analysis,
triplicate analysis is recommended (~600 µl)